Topiramate aurovitas

Package leaflet: Information for the user

Topiramate Aurovitas, 25 mg, film-coated tablets
Topiramate Aurovitas, 50 mg, film-coated tablets
Topiramate Aurovitas, 100 mg, film-coated tablets
Topiramate Aurovitas, 200 mg, film-coated tablets
Topiramatum
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You as a user can also help by reporting any adverse reactions that occur after taking the medicine. For information on how to report adverse reactions – see section 4.
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 consult 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 symptoms, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Topiramate Aurovitas is and what it is used for
2. What you need to know before taking Topiramate Aurovitas
3. How to take Topiramate Aurovitas
4. Possible side effects
5. How to store Topiramate Aurovitas
6. Contents of the pack and other information

1. What Topiramate Aurovitas is and what it is used for

Topiramate Aurovitas belongs to a group of medicines called antiepileptic drugs. It is used:

• as monotherapy in the treatment of epileptic seizures in adults and children above 6 years of age.
• in combination with other medicines for the treatment of epileptic seizures in adults and children aged 2 years and above.
• for the prevention of migraine headaches in adults.

2. Important information before taking Topiramate Aurovitas

When not to take Topiramate Aurovitas

• if the patient is allergic to topiramate or any of the other ingredients of this medicine (listed in section 6). Migraine prophylaxis
• Topiramate Aurovitas must not be used during pregnancy.
• If the patient is of childbearing age, Topiramate Aurovitas must not be taken without

using highly effective contraception during treatment. See below in the section “Pregnancy,
breastfeeding and fertility – important advice for women”.
Epilepsy treatment

• Topiramate Aurovitas must not be used if the patient is pregnant, unless no other treatment method provides sufficient seizure control.
• If the patient is of childbearing age, Topiramate Aurovitas must not be used without highly effective contraception during treatment. The only exception is when Topiramate Aurovitas is the only medicine providing adequate seizure control and the patient plans to become pregnant. Talk to the doctor to ensure that the patient has received information about the risks of using Topiramate Aurovitas during pregnancy and the risk of seizures during pregnancy. See below in the section “Pregnancy, breastfeeding and fertility – important advice for women”.

Please read the patient guide provided by your doctor or
scan the QR code (see section 6 “Contents of the pack and other information”).
A patient card is included in the Topiramate Aurovitas packaging, reminding of the risks
associated with pregnancy.
If the patient is unsure whether any of the above conditions apply, they should
consult their doctor or pharmacist before taking Topiramate Aurovitas.
Warnings and precautions
Before starting Topiramate Aurovitas, discuss with your doctor or
pharmacist if any of the following apply:

• kidney problems, especially kidney stones or dialysis
• abnormalities in blood and body fluids (metabolic acidosis)
• liver disorders
• vision problems, especially glaucoma
• growth disorders
• if a high-fat diet (ketogenic diet) is being used
• if the patient is a woman of childbearing age. Topiramate Aurovitas taken during pregnancy may harm the unborn child. Highly effective contraception must be used during treatment and for at least 4 weeks after the last dose of Topiramate Aurovitas. Further information is provided in the section “Pregnancy, breastfeeding and fertility”.
• if the patient is pregnant. Topiramate Aurovitas taken during pregnancy may harm the unborn child.

If the patient is unsure whether any of the above conditions apply, they should
consult their doctor before starting Topiramate Aurovitas.
If the patient has epilepsy, it is important not to stop taking the medicine without consulting
their doctor.
It is important that the patient does not stop taking the medicine without first consulting their doctor.
The patient should consult their doctor before taking any medicine containing
topiramate prescribed as a substitute for Topiramate Aurovitas.
During treatment with Topiramate Aurovitas, the patient may lose weight; therefore, body weight should be monitored regularly during treatment. If the patient loses too much weight or if a child taking this medicine does not gain sufficient weight, consult the doctor.
In a small number of people treated with antiepileptic medicines such as Topiramate
Aurovitas, thoughts of harming oneself or suicide have occurred.
If such thoughts occur, contact the doctor immediately.
Topiramate Aurovitas may cause severe skin reactions; if a rash and/or blisters on the skin occur, inform the doctor immediately (see also section 4. “Possible side effects”).
Topiramate Aurovitas may rarely increase blood ammonia levels
(detected in blood tests), which may lead to changes in brain function, especially
if the patient is also taking a medicine containing valproic acid or sodium valproate.
As this may be an acute condition, inform the doctor immediately if any of the
following adverse effects occur (see also section 4 “Possible side effects”):

• difficulty thinking, remembering or solving problems
• reduced alertness or consciousness
• feeling very sleepy with lack of energy.

The risk of these symptoms may increase when high doses of
Topiramate Aurovitas are used.
Topiramate Aurovitas and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take. Topiramate Aurovitas
may interact with other medicines. Therefore, the dose of the patient's medicines may sometimes need to be adjusted or the dose of Topiramate Aurovitas changed accordingly.
In particular, inform the doctor or pharmacist if any of the following are being used:

• other medicines that have harmful effects or reduce thinking, concentration or muscle coordination (e.g., central nervous system depressants such as muscle relaxants and sedatives).
• hormonal contraceptives. Topiramate Aurovitas may reduce the effectiveness of hormonal contraceptives. An additional barrier method of contraception, such as a condom or diaphragm/cervical cap, should be used. Discuss with the doctor the best method of contraception to use during treatment with Topiramate Aurovitas.

Tell the doctor if menstrual bleeding changes while using
hormonal contraceptives and Topiramate Aurovitas. Irregular bleeding may occur. In such a case, continue using hormonal contraceptives and inform the doctor.
Keep a list of all medicines being taken. Show this list to the doctor and pharmacist when starting a new treatment.
The use of other medicines such as antiepileptic drugs, risperidone, lithium, hydrochlorothiazide,
metformin, pioglitazone, glibenclamide, amitriptyline, propranolol, diltiazem, venlafaxine,
flunarizine, St John's wort (Hypericum perforatum) (a herbal preparation used in the
treatment of depression), warfarin (an anticoagulant), should be discussed with the doctor or
pharmacist.
If the patient is unsure whether the above text applies to them, they should consult their doctor or pharmacist before taking Topiramate Aurovitas.
Topiramate Aurovitas with food, drink and alcohol
Topiramate Aurovitas can be taken with or without food. Drink plenty of fluids during the day to help prevent kidney stone formation while taking Topiramate Aurovitas.
Alcohol should be avoided during treatment with Topiramate Aurovitas.
Pregnancy, breastfeeding and fertility
Important advice for women of childbearing potential
Topiramate Aurovitas may harm the unborn child. Women of childbearing age should discuss other possible treatment options with their doctor. At least once a year, visit the doctor to review treatment and discuss risks.
Migraine prophylaxis:

• Topiramate Aurovitas must not be used during pregnancy for migraine prevention.
• Topiramate Aurovitas must not be used in women of childbearing age unless a highly effective method of contraception is used.
• Before starting Topiramate Aurovitas in a woman of childbearing age, a pregnancy test should be performed.

Epilepsy treatment:

• Topiramate Aurovitas must not be used during pregnancy for epilepsy treatment, unless no other treatment method provides sufficient seizure control.
• Topiramate Aurovitas must not be used in women of childbearing age unless a highly effective method of contraception is used. The only exception is when Topiramate Aurovitas is the only medicine providing adequate seizure control and the patient plans to become pregnant. Talk to the doctor to ensure the patient has received information about the risks of using Topiramate Aurovitas during pregnancy and the risk of seizures during pregnancy, which may put the patient or unborn child at risk.
• Before starting Topiramate Aurovitas in a woman of childbearing age, a pregnancy test should be performed.

Risk of using topiramate during pregnancy (regardless of the condition being treated with topiramate):
There is a risk of harm to the unborn child if Topiramate Aurovitas is used during pregnancy.

• Using Topiramate Aurovitas during pregnancy increases the risk of congenital malformations in the child. In women taking topiramate, congenital malformations occur in approximately 4–9 out of 100 children. For comparison, this rate is 1–3 out of 100 children born to women who do not have epilepsy and do not take antiepileptic medicines. In particular, cleft lip (cleft of the upper lip) and cleft palate (cleft of the palate) have been observed. In male newborns, a developmental defect of the penis (hypospadias) may also occur. These malformations may develop early in pregnancy, even before the patient knows she is pregnant.

• When Topiramate Aurovitas 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 medicines.

• When Topiramate Aurovitas 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 at birth, compared to 5% of newborns in women without epilepsy who did not take antiepileptic medicines.

• If in doubt, ask the doctor about the risks during pregnancy.

• Other medicines used to treat this condition may be available that carry a lower risk of congenital malformations.

Need for contraception in women of childbearing age:

• Women of childbearing age should discuss with their doctor the possibility of using alternative treatment methods instead of Topiramate Aurovitas. If the decision is made to start treatment with Topiramate Aurovitas, highly effective contraception must be used during treatment and for at least 4 weeks after the last dose of Topiramate Aurovitas.
• One highly effective contraceptive method (such as an intrauterine device) or two complementary methods of contraception, such as an oral contraceptive combined with a mechanical method (such as a condom or diaphragm/cervical cap), should be used. Talk to the doctor to find out which contraceptive method is most suitable for the patient.
• If the patient is using hormonal contraceptives, topiramate may reduce their effectiveness. Therefore, an additional barrier method of contraception (such as a condom or diaphragm/cervical cap) should be used.
• If irregular menstrual bleeding occurs, inform the doctor.

Use of Topiramate Aurovitas in girls:
Parents or guardians of a girl being treated with Topiramate Aurovitas must contact the doctor immediately when the girl has her first menstrual period. The doctor will inform them about the risk to the unborn child from exposure to topiramate during pregnancy and the need to use a highly effective method of contraception.
If the patient wishes to become pregnant while taking Topiramate Aurovitas:

• Make an appointment with the doctor.
• Do not stop using contraception until this issue has been discussed with the doctor.
• If the patient is taking Topiramate Aurovitas for epilepsy, do not stop taking it without consulting the doctor, as the condition may worsen.
• The doctor will reassess the treatment and alternative treatment options. The doctor will inform the patient about the risks of using Topiramate Aurovitas during pregnancy. The doctor may also refer the patient to another specialist.

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

• Make an urgent appointment with the doctor.
• If Topiramate Aurovitas is being used for migraine prophylaxis, stop taking the medicine immediately and contact the doctor, who will assess whether alternative treatment is necessary.
• If the patient is taking Topiramate Aurovitas for epilepsy, do not stop taking it without consulting the doctor, as this may worsen the condition. Worsening epilepsy may put the patient or unborn child at risk.
• The doctor will reassess the treatment and alternative treatment options. The doctor will inform the patient about the risks of using Topiramate Aurovitas during pregnancy. The doctor may also refer the patient to another specialist.
• If Topiramate Aurovitas is used during pregnancy, the patient will remain under close monitoring to assess the development of the unborn child.

Please read the patient guide provided by your doctor. The
patient guide can also be obtained by scanning the QR code; see section 6. “Contents of the pack and
other information”. A patient card is included in the Topiramate Aurovitas packaging, reminding of the risks
associated with using topiramate during pregnancy.
Breastfeeding
The active substance of Topiramate Aurovitas (topiramate) passes into human milk. In infants breastfed by mothers taking this medicine, adverse effects such as diarrhoea, drowsiness, irritability and poor weight gain have occurred. Therefore, the doctor will discuss with the patient whether to stop breastfeeding or stop using Topiramate Aurovitas. The doctor will consider the importance of the medicine for the mother and the risk to the child.
Mothers taking Topiramate Aurovitas during lactation must inform the doctor immediately if they notice any change in their child's behaviour.
Driving and operating machinery
Dizziness, fatigue and visual disturbances may occur while taking Topiramate Aurovitas. Do not drive, operate any machinery or use tools until medical advice has been sought.
Topiramate Aurovitas contains lactose
If the doctor has informed the patient of an intolerance to certain sugars, consult the doctor before taking this medicine.
Topiramate Aurovitas contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Topiramate Aurovitas

This medicine should always be used exactly as directed by the doctor. In case of doubt, consult
the doctor or pharmacist.
Girls and women of childbearing age
Treatment with Topiramate Aurovitas should be initiated and supervised by a doctor experienced
in the treatment of epilepsy or migraine. A visit to the doctor for treatment monitoring should be made
at least once a year.

• The doctor usually starts treatment with a low dose of Topiramate Aurovitas and gradually increases it until the optimal dose for the individual patient is established.
• Topiramate Aurovitas tablets should be swallowed whole. Chewing the tablets is not recommended, as they may leave a bitter taste.
• Topiramate Aurovitas can be taken before, during, or after meals. While taking Topiramate Aurovitas, it is important to drink plenty of fluids to avoid the formation of kidney stones.

Taking more Topiramate Aurovitas than prescribed

• Contact the doctor immediately. Also, bring the medicine packaging with you.
• The patient may experience the following symptoms: drowsiness, feeling tired or less alert, lack of coordination, speech or concentration difficulties, double or blurred vision, dizziness due to low blood pressure, feelings of depression or agitation, abdominal pain, or seizures.

Overdose may also occur when taking other medicines together with Topiramate Aurovitas.
Missing a dose of Topiramate Aurovitas

• If a dose is missed, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue with the regular dosing schedule. If two or more doses are missed, contact the doctor.
• Do not take a double dose (two doses at the same time) to make up for a missed dose.

Stopping Topiramate Aurovitas treatment
Do not stop treatment unless instructed by the doctor. Symptoms of the underlying condition may return after discontinuation of therapy. If the doctor decides to discontinue treatment, the dose of the medicine may be gradually reduced over several days.
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 get them.
You should tell your doctor or pharmacist if any of the following adverse reactions occur:

Very common (may affect more than 1 in 10 people)

• Depression (new onset or worsening of existing depression).

Common (may affect up to 1 in 10 people)

• Seizure attacks
• Anxiety, irritability, mood changes, confusion, disorientation
• Difficulty concentrating, slowed thinking, memory loss, memory disturbances (new onset, sudden change or increased severity)
• Kidney stones, frequent or painful urination.

Uncommon (may affect up to 1 in 100 people)

• Metabolic acidosis (may cause breathing problems including shortness of breath, loss of appetite, nausea, vomiting, excessive tiredness, and rapid, irregular heartbeat)
• Reduced or absent sweating (particularly in young children exposed to high environmental temperatures)
• Thoughts or attempts of severe self-harm
• Loss of part of the visual field.

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

• Glaucoma, characterized by fluid buildup in the eye chamber, leading to increased intraocular pressure, eye pain, and impaired vision
• Difficulty thinking, remembering, or solving problems, reduced alertness or consciousness, feeling extremely sleepy with lack of energy – may be symptoms of high blood ammonia levels (hyperammonemia), which may lead to brain dysfunction (hyperammonemia-related encephalopathy)
• Severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis – may present with or without blisters. Skin irritation, ulcers or swelling in the mouth, throat, nose, eyes, and genital areas. Skin rashes may progress to severe, widespread skin damage (peeling of the outer layer of skin and mucous membranes), which may be life-threatening.

Frequency not known (cannot be estimated from available data):

• Inflammation of the eye (uveitis) with the following symptoms: eye redness, pain, light sensitivity, tearing, floaters, or blurred vision.

Other adverse reactions that should be reported to your doctor or pharmacist:

Very common (may affect more than 1 in 10 people)

• Inflammation of the mucous membranes of the nose and throat
• Tingling, pain, and/or numbness in various parts of the body
• Drowsiness, fatigue
• Dizziness
• Nausea, diarrhoea
• Weight loss.

Common (may affect up to 1 in 10 people)

• Anaemia (reduced number of red blood cells)
• Allergic reactions (such as skin rash, redness, itching, facial swelling, hives)
• Loss of appetite, reduced appetite
• Aggression, agitation, anger, unusual behaviour
• Difficulty falling asleep and waking up
• Difficulty speaking or speech disturbances, slurred speech
• Motor incoordination or lack of coordination, feeling unbalanced while walking
• Reduced ability to perform routine tasks
• Reduced, lost, or absent sense of taste
• Involuntary tremors or twitching; rapid, uncontrolled eye movements
• Visual disturbances such as double vision, blurred vision, reduced visual field, focusing difficulties
• Sensation of spinning (dizziness), ringing in the ears, ear pain
• Shortness of breath
• Cough
• Nosebleeds
• Fever, malaise, loss of strength
• Vomiting, constipation, abdominal pain or discomfort, indigestion, stomach or intestinal infection
• Dry mouth
• Hair loss
• Itching
• Joint pain or swelling, muscle cramps or twitching, muscle pain or weakness, chest pain
• Weight gain.

Uncommon (may affect up to 1 in 100 people)

• Reduced platelet count (blood cells responsible for clotting), reduced white blood cell count (cells that fight infection), low blood potassium levels
• Increased liver enzyme activity, increased number of eosinophils in blood (a type of white blood cell)
• Swelling of lymph nodes in the neck, armpits, and groin
• Increased appetite
• Elevated mood
• Hallucinations (seeing, hearing, or feeling things that are not there), severe mental disturbances (psychosis)
• Inability to feel or express emotions, unusual suspiciousness, panic attacks
• Reading difficulties, speech disturbances, handwriting difficulties
• Restlessness, increased mental and physical activity
• Slowed thinking, reduced level of alertness
• Weak or slow body movements, involuntary abnormal or repetitive muscle contractions
• Fainting
• Abnormal sensation to touch; impaired sense of touch
• Impaired, distorted, or absent sense of smell
• Unusual sensation or feeling that precedes migraine or certain types of seizures
• Dry eyes, light sensitivity, involuntary eye twitching, tearing
• Hearing loss or reduced hearing, hearing loss in one ear
• Slow or irregular heartbeat, palpitations
• Low blood pressure, low blood pressure upon standing (which in some patients taking Topiramate Aurovitas may result in feeling faint, dizzy, or losing consciousness when standing up or sitting down suddenly)
• Hot flushes, feeling of warmth
• Pancreatitis
• Excessive gas, heartburn, feeling of fullness in the stomach or bloating
• Bleeding gums, excessive salivation, drooling, bad breath
• Excessive fluid intake and increased thirst
• Skin discoloration
• Muscle stiffness, flank pain
• Blood in urine, urinary incontinence, sudden urge to urinate, flank pain or kidney pain
• Difficulty achieving or maintaining erection, sexual dysfunction
• Influenza-like symptoms
• Cold sensation in fingers and toes
• Feeling of alcohol intoxication
• Learning difficulties.

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

• Abnormally elevated mood
• Loss of consciousness
• Vision loss in one eye, transient blindness, night blindness
• Lazy eye
• Swelling of the eye and tissues around the eye
• Numbness, tingling, and skin colour changes (pale, blue, then red) in fingers and toes upon cold exposure
• Hepatitis, liver failure
• Unpleasant body odour
• Discomfort in upper and lower limbs
• Kidney disorders.

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

• Macular degeneration – a disease of the macula (the central part of the retina responsible for sharpest vision). If you notice any changes in vision or impaired vision, you should contact your doctor.

Children
Adverse reactions in children are generally similar to those observed in adults, but the following adverse reactions may occur more frequently in children than in adults:

• Problems with concentration
• Increased blood acid levels (metabolic acidosis)
• Thoughts of severe self-harm
• Fatigue
• Decreased or increased appetite
• Aggression, unusual behaviour
• Difficulty falling asleep and waking up
• Feeling unbalanced while walking
• Malaise
• Low blood potassium levels
• Inability to feel or express emotions
• Tearing
• Slow or irregular heartbeat.

Other adverse reactions that may occur in children:

Common (may affect up to 1 in 10 people)

• Sensation of spinning (vestibular dizziness)
• Vomiting
• Fever.

Uncommon (may affect up to 1 in 100 people)

• Increased number of eosinophils in blood (a type of white blood cell)
• Hyperactivity
• Feeling of warmth
• Learning difficulties.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Topiramate Aurovitas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, container, or blister pack following: EXP. The expiry date refers to the last day of the stated month.
Store below 25°C.
Medicines must not be disposed of via the sewage system 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 packaging and other information

What Topiramate Aurovitas contains

• The active substance is topiramate.

Each coated tablet contains 25 mg of topiramate.
Each coated tablet contains 50 mg of topiramate.
Each coated tablet contains 100 mg of topiramate.
Each coated tablet contains 200 mg of topiramate.

• Other ingredients are:
  Tablet core: microcrystalline cellulose, lactose monohydrate, pregelatinized corn starch, sodium carboxymethyl starch (type A), magnesium stearate.

Coating: hypromellose 2910 (3 cp and 6 cp), titanium dioxide (E 171), macrogol 400,
polysorbate 80, iron oxide yellow (E 172) (for 50 mg and 100 mg), iron oxide red (E 172)
(for 200 mg only).

What Topiramate Aurovitas looks like and contents of the pack
Coated tablets.
Topiramate Aurovitas 25 mg, coated tablets:
White, round, biconvex coated tablets, with "E" engraved on one side and "22" on the other side.
Topiramate Aurovitas 50 mg, coated tablets:
Light yellow, round, biconvex coated tablets, with "E" engraved on one side and "33" on the other side.
Topiramate Aurovitas 100 mg, coated tablets:
Dark yellow, round, biconvex coated tablets with bevelled edges, with "E" engraved on one side and "23" on the other side.
Topiramate Aurovitas 200 mg, coated tablets:
Pink, round, biconvex coated tablets with bevelled edges, with "E" engraved on one side and "24" on the other side.
Topiramate Aurovitas coated tablets are available in blister packs and HDPE containers.

Pack sizes:
Blister packs:
28 and 60 coated tablets.
HDPE containers:
28 and 60 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D, lok. 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Poland: Topiramate Aurovitas
Portugal: Topiramato Limeg

Other sources of information
The most up-to-date approved information (Patient Information Leaflet) for this medicinal product is available by scanning the QR code below with a smartphone. The same information is also available on the following website (URL):