Qsiva

B. PATIENT INFORMATION LEAFLET

Patient Information Leaflet included in the packaging: information for the patient

Qsiva, 3.75 mg+23 mg, prolonged-release hard capsules
Qsiva, 7.5 mg+46 mg, prolonged-release hard capsules
Qsiva, 11.25 mg+69 mg, prolonged-release hard capsules

Qsiva, 15 mg+92 mg, prolonged-release hard capsules

Phentermine + topiramate

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What Qsiva is and what it is used for
• 2. Important information before taking Qsiva
• 3. How to take Qsiva
• 4. Possible side effects
• 5. How to store Qsiva
• 6. 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 them together helps to reduce body weight better than taking either one alone.
Qsiva is used, in addition to a low-calorie diet and physical activity, to help adults lose weight and maintain weight loss. It is recommended for:

• obese patients with a body mass index (BMI) of 30 kg/m² or more, or
• overweight patients with a body mass index of 27 kg/m² or more and weight-related health problems, such as high blood pressure, diabetes, or abnormal blood fat levels

2. Important information before taking Qsiva

When not to take Qsiva:

• if you are allergic to phentermine, topiramate, or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to medicines called sympathomimetic amines, which are used to treat asthma, a blocked nose, or eye disorders
• if you are pregnant or of childbearing age, unless you are using a highly effective method of contraception (for more information, see the section "Pregnancy and breast-feeding"). You should discuss the choice of contraceptive method with your doctor.
• you must read the Patient Information Leaflet provided by your doctor. A patient card is included with the Qsiva packaging, which reminds you of the risk associated with pregnancy.
• if you are taking medicines called monoamine oxidase inhibitors, or if you have taken them in the last 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 you are taking other medicines to help you lose weight

Warnings and precautions

Before starting or during treatment with Qsiva, you should discuss with your doctor if:

• you are of childbearing age. Qsiva taken during pregnancy may harm the unborn baby. During treatment and for at least 4 weeks after the last dose of Qsiva, you should use a highly effective method of contraception. For more information, see the section "Pregnancy and breast-feeding".
• you are pregnant: Qsiva taken during pregnancy may harm the unborn baby.
• you have mood disorders or depression, or have had them in the past. Qsiva may worsen these conditions. Your doctor will closely monitor you if you have a history of these conditions. You should immediately inform your doctor if you notice unusual changes in mood or behavior. Qsiva is not recommended for use in patients with:
• recurrent major depression in their medical history
• periods of depression and periods of abnormally elevated mood, called bipolar affective disorders
• psychosis
• currently experiencing moderate or severe depression
• you have had suicidal thoughts or have attempted suicide. Qsiva may increase the frequency of suicidal thoughts. You should immediately inform your doctor if you notice suicidal thoughts.
• you have heart problems or vascular disease. Qsiva may cause an increase in heart rate. Regular measurement of resting heart rate by your doctor is recommended for all patients during treatment. You should inform your doctor if you experience very rapid heartbeats at rest during treatment with Qsiva. Qsiva is not recommended for use in patients with:
• myocardial infarction in the last 6 months
• high risk of cardiovascular problems, including those with advanced diseases, such as stroke in the last 3 months, life-threatening irregular heartbeat, or certain types of heart failure
• you have had kidney stones or if one of your biological relatives has had kidney stones, or if you have high blood calcium levels. Qsiva may increase the risk of kidney stones. Therefore, it is recommended that all patients taking Qsiva drink plenty of waterevery day.
• you have acute eye problems

If you experience sudden worsening of vision or blurred vision, or eye pain, you should stop taking Qsiva and immediately contact your doctor or pharmacist.
These effects may be symptoms of eye diseases, such as glaucoma or increased eye pressure.

• you have too much acid in your blood. Qsiva may increase the level of acid in your blood. Your doctor may want to regularly measure the amount of acid and bicarbonate in your blood and may need to reduce the dose or stop treatment with Qsiva.
• you have reduced kidney or liver function. Qsiva is not recommended for patients with severely reduced liver function, end-stage renal failure, or patients on dialysis.
• you have hyperthyroidism. Qsiva is not recommended for use in patients with hyperthyroidism.

The active substance phentermine may increase the patient's energy or excitement level and therefore has the potential for 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

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Do not take Qsiva and tell your doctorif you are taking:

• other medicines to help you lose weight
• medicines called monoamine oxidase inhibitors, or if you have taken them in the last 14 days, such as
• iproniazid: used to treat depression
• isoniazid: used to treat tuberculosis
• phenelzine, tranylcypromine: used to treat depression or Parkinson's disease

You should also tell your doctor or pharmacistif you are taking:

• another medicine containing phentermine or topiramate. Qsiva is not recommended as a substitute for these medicines.
• hormonal contraceptives. Taking Qsiva with hormonal contraceptives may reduce their effectiveness and cause irregular bleeding. Contraceptive effectiveness may be reduced even if there is no bleeding. You should use an additional, mechanical method of contraception, such as a condom or diaphragm/cervical cap. You should discuss with your doctor the best method of contraception to use during treatment with Qsiva. Irregular bleeding may occur. If it does, you should continue to use hormonal contraceptives and inform your doctor.
• medicines that reduce alertness, such as
• medicines used to treat epilepsy or to sedate
• sedatives, sleep-inducing, or muscle-relaxing medicines, such as diazepam
• other sleep-inducing medicines
• medicines that increase urine production, such as hydrochlorothiazide. It is recommended that your doctor monitor your potassium levels in your blood if you are taking non-potassium-sparing diuretics.
• medicines used to treat epilepsy, such as phenytoin, carbamazepine, valproic acid
• alfentanil: a pain-relieving medicine used during surgery with anesthetics
• fentanyl: a strong pain-relieving medicine
• cyclosporin: a medicine used to suppress the immune system, to treat severe skin diseases, or severe eye inflammation or joint inflammation
• dihydroergotamine, ergotamine: a medicine used to treat migraines
• tacrolimus: a medicine used to prevent transplant rejection and to treat continuous 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. It is recommended that your doctor monitor your lithium levels during treatment with Qsiva.
• pimozide: a medicine used to treat mental disorders
• digoxin: a medicine used to treat heart failure and irregular heartbeat
• quinidine: a medicine used to treat irregular heartbeat
• proguanil: a medicine used to treat and prevent malaria
• omeprazole: a medicine that reduces stomach acid production
• medicines called carbonic anhydrase inhibitors, such as
• zonisamide: used to treat epilepsy
• acetazolamide: used to treat increased eye pressure, abnormal fluid retention, breathing problems, high altitude disease, epilepsy
• dichlorphenamide: used to treat paroxysmal nocturnal hemoglobinuria
• medicines used to treat diabetes, such as pioglitazone, metformin, glibenclamide, insulin. It is recommended that your doctor regularly monitor your blood sugar levels while taking Qsiva with one of these medicines. It is also recommended that your doctor regularly measure your bicarbonate levels if you are taking metformin.

Qsiva and alcohol

You should avoid drinking alcohol during treatment with Qsiva, as alcohol may increase the risk of side effects.

Pregnancy and breast-feeding

• PregnancyImportant advice for women of childbearing age Women of childbearing age should discuss other possible treatment options with their doctor. At least once a year, you should visit your doctor to review your treatment and discuss the risks. Do not takethis medicine if you are pregnant.

This medicine must not be taken if you may become pregnant, unless you are using a highly effective method of contraception.
Before starting treatment with Qsiva, women of childbearing age should have a pregnancy test.
The risk associated with taking topiramate (one of the active substances in Qsiva, also used to treat epilepsy) during pregnancy:

• Topiramate taken during pregnancy may harm the fetus and inhibit its development. The risk of birth defects in the child is increased. In women taking topiramate, birth defects occur in about 4-9 out of 100 children. For comparison, this figure is 1-3 out of 100 children born to women who do not have epilepsy and are not taking antiepileptic medicines. In particular, cleft lip (cleft lip) and cleft palate (cleft palate) have been observed. In newborn boys, a developmental defect of the penis (hypospadias) may also occur.

These defects may develop early in pregnancy, before the patient knows she is pregnant.

• The risk of the child developing autism spectrum disorders, intellectual disability, or attention deficit hyperactivity disorder (ADHD) may be 2 to 3 times higher than in children born to women with epilepsy who are not taking antiepileptic medicines.
• When Qsiva is taken during pregnancy, the baby may be smaller and have a lower than expected birth weight. In one study, 18% of children whose mothers took topiramate during pregnancy were smaller and weighed less than expected, while in women without epilepsy who did not take antiepileptic medicines, this figure was 5% of newborns.

Necessity of contraception in women of childbearing age:

• Women of childbearing age should discuss the possibility of using other treatment options instead of Qsiva with their doctor. If the decision is made to start treatment with Qsiva, you should use highly effective contraception during treatment and for at least 4 weeks after the last dose of Qsiva.
• You should use one highly effective contraceptive method (such as an intrauterine device) or two complementary contraceptive methods, such as a contraceptive pill, in combination with a mechanical contraceptive method (such as a condom or diaphragm/cervical cap). You should discuss with your doctor which contraceptive method will be most suitable for you.
• If you are taking hormonal contraceptives, topiramate may reduce their effectiveness. Therefore, you should use an additional, mechanical method of contraception. If you experience irregular bleeding, you should inform your doctor.
• You should stop taking Qsiva immediately and tell your doctor if you do not have a menstrual period or if you suspect you may be pregnant.

If you want to become pregnant while taking Qsiva:

• You should make an appointment with your doctor.
• You should not stop using contraception until you have discussed this with your doctor.

If you become pregnant or suspect you may be pregnant while taking Qsiva:

• You should make an urgent appointment with your doctor.
• You should stop taking Qsiva immediately and inform your doctor.

Your doctor will inform you about the risks associated with taking Qsiva during pregnancy.
You must read the Patient Information Leaflet provided by your doctor.
A patient card is included with the Qsiva packaging, which reminds you of the risk associated with taking topiramate during pregnancy.

Breast-feeding

Breast-feeding is not recommended during treatment with Qsiva, as the medicine may pass into breast milk. Your doctor will decide whether to stop breast-feeding or stop Qsiva.

Driving and using machines

You should avoid driving or operating machinery during treatment with Qsiva if your reaction ability is reduced. While taking one of the active substances in the medicine, drowsiness, dizziness, vision disturbances, and blurred vision have been reported. Before engaging in any of these activities, you should wait until you know how Qsiva affects you.
Qsiva, 3.75 mg+23 mg prolonged-release hard capsules

Qsiva contains sucrose

Qsiva contains a small amount of sugar called sucrose. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking Qsiva.
Qsiva, 7.5 mg+46 mg, 11.25 mg+69 mg, and 15 mg+92 mg prolonged-release hard capsules

Qsiva contains sucrose, tartrazine, and orange yellow FCF

Qsiva contains a small amount of sugar called sucrose. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking Qsiva.
The dyes tartrazine and orange yellow FCF may cause allergic reactions.

3. How to take Qsiva

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Treatment with Qsiva should be started and supervised by a doctor with experience in weight management. Women of childbearing age should visit their doctor at least once a year to review their treatment.
Your doctor will determine the correct dose for you.
Your doctor will start treatmentwith a low dose of 1 Qsiva 3.75 mg+23 mg capsule once a day for 14 days. There may be reasons why your doctor will keep this dose for the entire treatment, e.g., if you have kidney or liver disease. If you have kidney disease, your doctor may also start with a low dose every other day instead of every day.
The recommended doseis 1 Qsiva 7.5 mg+46 mg capsule once a day after 14 days of taking Qsiva 3.75 mg+23 mg capsules. You will take this dose for about 3 months. If after this time you have not lost at least 5% of your initial body weight, your doctor may stop treatment.
If you have lost at least 5% of your body weight and are tolerating treatment well, your doctor may recommend continuing treatment with the same dose. If your body weight remains high and your doctor recommends a higher dose, you will take 1 Qsiva 11.25 mg+69 mg capsule once a day for 14 days. Then the dose can be increased to 1 Qsiva 15 mg+92 mg capsule once a day. If treatment is stopped at a high dose, it is recommended to do so gradually, taking the dose every other day for at least 1 week before stopping treatment.
Your doctor will also want to closely monitor your progress. For this reason, you should 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.

How to take it

The capsule should be swallowed whole, once a day, in the morning, with a glass of water or another sugar-free drink. Do not crush or chew it. The capsules can be taken with or without food.

If you take more Qsiva than you should

In this case, you should contact your doctor or go directly to the hospital. You should take the medicine packaging with you.

If you forget to take Qsiva

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

Stopping Qsiva treatment

You should not change the dose of Qsiva or stop treatment without your doctor's advice. Stopping treatment suddenly increases the risk of seizures. It is recommended to gradually reduce the dose if you are taking the highest dose and need to stop treatment.
You should contact your doctor for advice on weight management and possible changes to the doses of other medicines you may be taking.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Qsiva can cause side effects, although not everybody gets them.
Side effects may occur with the following frequencies:
Very common(may affect more than 1 in 10 people):

• dry mouth
• constipation
• abnormal sensations, such as tingling, prickling, burning, or numbness

Common(may affect up to 1 in 10 people):

• loss of appetite, taste disturbances
• sleep disturbances, depression, anxiety, irritability
• headache
• dizziness, concentration disturbances, fatigue, poor memory
• reduced sense of touch or feeling
• blurred vision, dry eye
• rapid heartbeat
• nausea, diarrhea, abdominal pain, indigestion
• hair loss
• thirst, nervousness

Uncommon(may affect up to 1 in 100 people):

• urinary tract infection
• anemia
• low potassium levels in the blood, low blood sugar levels
• fluid retention, dehydration
• increased appetite
• nervousness
• reduced or increased sexual desire
• mood changes, emotional disturbances
• excitement, restlessness
• confusion, mood swings, lack of interest
• sleep disturbances, including unusual dreams, nightmares
• crying, stress, anger
• panic attack, paranoia
• partial or complete memory loss
• drowsiness, lethargy
• uncontrolled trembling
• cognitive function disturbances, speech disturbances
• reduced sense of taste
• migraine
• increased motor activity
• other nervous system disorders, not affecting the brain and spinal cord
• fainting
• a disorder causing a strong urge to move your legs
• poor coordination
• smell disturbances
• eye pain, eyelid spasms
• unpleasant eye sensitivity to light
• perceptual flashes of light in the field of vision
• double vision, eye itching
• ringing in the ears
• rapid heartbeat
• sudden flushing of the face
• low or high blood pressure
• cough, nosebleeds
• breathing difficulties
• throat and voice box pain
• stuffy nose or sinuses, runny nose
• gas, belching
• acid reflux from the stomach into the esophagus, vomiting
• itching, hives, rash, redness of the skin, dry skin
• increased sweating, acne, unusual skin odor
• unusual hair structure
• arm and leg pain, muscle pain, back pain, joint pain
• muscle spasms, muscle weakness, muscle trembling
• kidney stones
• frequent need to urinate with little urine production, difficulty urinating
• increased nighttime urination
• erectile dysfunction
• menstrual disturbances
• weakness, unusual feelings
• swelling of the hands and (or) feet due to fluid accumulation
• increased energy, chest pain, feeling cold or hot
• reduced levels of: bicarbonate, potassium in the blood
• abnormal liver function test results
• reduced kidney function, measured by the amount of creatinine in the blood

Rare(may affect up to 1 in 1,000 people)

• respiratory tract infection
• sinusitis, flu, bronchitis
• fungal infection
• ear infection
• excessive acid in the body due to a metabolic disorder, gout
• suicidal thoughts, aggression
• inability to feel pleasure, including reduced motivation
• grief reaction
• teeth grinding, food aversion
• hallucinations, disorientation
• stuttering
• tingling sensation
• increased tear production
• increased eye pressure, eye bleeding
• deafness, ear pain
• heart rhythm disturbances causing very rapid activity in the atria of the heart, irregular heartbeat
• deep vein thrombosis
• dry throat, runny nose
• bad breath, gum pain, tongue inflammation, burning sensation in the tongue
• petechiae, infrequent bowel movements
• gallstones or gallstone-related diseases
• gallbladder inflammation
• brittle nails
• muscle tension
• unusual urine odor
• gait disturbances
• falls
• increased creatinine levels in the blood
• increased glucose levels in the blood

Frequency not known(frequency cannot be estimated from the available data)

• stomach and intestinal inflammation caused by a virus
• hypersensitivity
• talkativeness, attempted suicide
• seizures
• nerve pain
• temporary blindness, dilated pupils, cataract
• certain eye diseases with degeneration of the inner layer of the eye, which can lead to loss of central vision
• hearing impairment, fluid accumulation in the middle ear
• heart failure
• nasal polyps, acute respiratory failure
• difficulty swallowing, discomfort in the mouth, gagging
• severe allergic reaction causing facial or throat swelling
• acute kidney damage
• feeling of a foreign body
• reduced blood sugar levels
• increased levels in the blood of: hemoglobin A1c, thyroid-stimulating hormone, specific fats in the blood called triglycerides
• eye inflammation (uveitis) with the following symptoms: eye redness, pain, sensitivity to light, eye tearing, floaters, or blurred vision.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw,
phone: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Qsiva

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

6. Contents of the pack and other information

What Qsiva contains

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

What Qsiva looks like and contents of the pack

Qsiva is a prolonged-release hard capsule, 2.31 cm long and 0.73 to 0.76 cm in diameter.
Qsiva, 3.75 mg+23 mg prolonged-release hard capsules
The Qsiva 3.75 mg+23 mg capsules have a purple cap with "VIVUS" printed on it and a purple body with "3.75/23" printed on it.
Qsiva, 7.5 mg+46 mg prolonged-release hard capsules
The Qsiva 7.5 mg+46 mg capsules have a purple cap with "VIVUS" printed on it and a yellow body with "7.5/46" printed on it.
Qsiva, 11.25 mg+69 mg prolonged-release hard capsules
The Qsiva 11.25 mg+69 mg capsules have a yellow cap with "VIVUS" printed on it and a yellow body with "11.25/69" printed on it.
Qsiva, 15 mg+92 mg prolonged-release hard capsules
The Qsiva 15 mg+92 mg capsules have a yellow cap with "VIVUS" printed on it and a white body with "15/92" printed on it.
Qsiva capsules are packaged in an HDPE bottle containing 14 or 30 capsules with a PE child-resistant closure and a desiccant.

Marketing authorization holder and manufacturer

Marketing authorization holder

VIVUS BV
Strawinskylaan 4117
1077 ZX Amsterdam
Netherlands

Manufacturer

Catalent Germany Schorndorf GmbH
Steinbeisstrasse 1-2
73614 Schorndorf
Germany
Date of last revision of the leaflet:03.04.2024
Detailed information on 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).