Topiramate Doc Generici

PACKAGE LEAFLET: Information for the patient

TOPIRAMATE DOC Generics 25 mg, film-coated tablets, 50 mg, film-coated tablets, 100 mg, film-coated tablets, 200 mg, film-coated tablets

Generic Medicine
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist.

Contents of this leaflet:

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

1. What TOPIRAMATO DOC Generici is and what it is used for

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

• alone for the treatment of epileptic seizures in adults and children over 6 years of age
• in combination with other medicines for the treatment of epileptic seizures in adults and children over 2 years of age
• for the prevention of migraine in adults

2. What you need to know before taking TOPIRAMATO DOC Generici

DO NOT take TOPIRAMATO DOC Generici

• If you are allergic to topiramate or to any of the other ingredients of this medicine (listed in section 6).
• for migraine prevention: if you are pregnant or if you are a woman of childbearing potential unless you are using an effective method of contraception (see section “Pregnancy, breastfeeding and fertility” for more information). You should discuss with your doctor which type of contraception is most suitable during treatment with TOPIRAMATO DOC Generici.

If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or pharmacist before using TOPIRAMATO DOC Generici.

Warnings and precautions

Talk to your doctor or pharmacist before taking TOPIRAMATO DOC Generici if:

• you have kidney problems, particularly kidney stones, or if you are undergoing renal dialysis
• you have a history of blood or body fluid disorders (metabolic acidosis)
• you have liver problems
• you have eye problems, particularly glaucoma
• you have growth problems
• your diet is high in fat (ketogenic diet)
• you are taking TOPIRAMATO DOC Generici for epilepsy treatment and you are pregnant or are a woman of childbearing potential (for further information, see section ‘Pregnancy, breastfeeding and fertility’).

If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or pharmacist before starting treatment with TOPIRAMATO DOC Generici.

It is important that you do not stop taking this medicine without first consulting your doctor.

You should also speak with your doctor before taking any other medicine containing topiramate that may be prescribed as an alternative to TOPIRAMATO DOC Generici.

While taking TOPIRAMATO DOC Generici, you may lose weight. Therefore, your weight should be monitored regularly during treatment. If you lose too much weight, or if a child taking this medicine does not gain sufficient weight, consult your doctor.

A small number of patients treated with antiepileptic medicines such as TOPIRAMATO DOC Generici have reported having thoughts of self-harm or suicide. If at any time you experience such thoughts, contact your doctor immediately.

TOPIRAMATO DOC Generici may rarely cause high levels of ammonia in the blood (see blood tests), which may lead to changes in brain function, especially if you are also taking a medicine called valproic acid or sodium valproate. Since this may be a serious condition, contact your doctor immediately if you experience any of the following symptoms (also see section 4 “Possible side effects”):

• difficulty thinking, remembering information, or solving problems
• reduced alertness or awareness
• feeling very drowsy and lacking energy

At higher doses of TOPIRAMATO DOC Generici, the risk of developing these symptoms may increase.

Other medicines and TOPIRAMATO DOC Generici

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription, vitamins, and herbal supplements.

TOPIRAMATO DOC Generici and certain other medicines may interact with each other. Sometimes, the dose of either TOPIRAMATO DOC Generici or your other medicines may need to be adjusted.

In particular, inform your doctor or pharmacist if you are taking:

• other medicines that impair or reduce mental function, concentration, or muscle coordination (e.g., central nervous system depressants such as muscle relaxants and sedatives).
• oral contraceptive pills. TOPIRAMATO DOC Generici may reduce the effectiveness of oral contraceptives. You should discuss with your doctor which type of contraception is most suitable during treatment with TOPIRAMATO DOC Generici.

Inform your doctor if you notice any changes in your menstrual bleeding while taking oral contraceptives and TOPIRAMATO DOC Generici.

Keep a list of all medicines you are taking. Show this list to your doctor or pharmacist before starting any new medicine.

Other medicines to discuss with your doctor or pharmacist include other antiepileptic medicines, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, gliburide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarizine, and St. John’s wort (Hypericum perforatum) (a herbal preparation used to treat depression).

If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or pharmacist before using TOPIRAMATO DOC Generici.

TOPIRAMATO DOC Generici with food and drink

You may take TOPIRAMATO DOC Generici during or between meals. Drink plenty of fluids throughout the day while taking TOPIRAMATO DOC Generici to help prevent kidney stone formation. Avoid drinking alcohol while taking TOPIRAMATO DOC Generici.

Pregnancy, breastfeeding and fertility

Migraine prevention:

TOPIRAMATO DOC Generici may harm the unborn baby. You must not use TOPIRAMATO DOC Generici if you are pregnant. You must not use TOPIRAMATO DOC Generici for migraine prevention if you are a woman of childbearing potential unless you are using an effective method of contraception. Ask your doctor about the most suitable type of contraception and whether TOPIRAMATO DOC Generici is appropriate for you. A pregnancy test must be performed before starting treatment with TOPIRAMATO DOC Generici.

Epilepsy treatment:

If you are a woman of childbearing potential, you should discuss with your doctor other possible treatments instead of TOPIRAMATO DOC Generici. If TOPIRAMATO DOC Generici is used, effective contraception is required. Ask your doctor which type of contraception is most suitable during treatment with TOPIRAMATO DOC Generici. A pregnancy test must be performed before starting treatment with TOPIRAMATO DOC Generici.

Talk to your doctor if you are planning a pregnancy. As with other antiepileptic medicines, there is a risk of harm to the unborn baby if TOPIRAMATO DOC Generici is used during pregnancy. Make sure you fully understand the risks and benefits of using TOPIRAMATO DOC Generici for epilepsy during pregnancy.

• If you take TOPIRAMATO DOC Generici during pregnancy, your baby has an increased risk of birth defects, particularly cleft lip (a split in the upper lip) and cleft palate (a split in the roof of the mouth). Male newborns may also have a malformation of the penis (hypospadias). These defects may occur early in pregnancy, even before you know you are pregnant.
• If you take TOPIRAMATO DOC Generici during pregnancy, your baby may be smaller than expected at birth. Speak with your doctor if you have questions about this risk.
• There may be other medicines available to treat your condition that carry a lower risk of birth defects. Inform your doctor immediately if you become pregnant while taking TOPIRAMATO DOC Generici. You and your doctor will need to decide whether to continue treatment with TOPIRAMATO DOC Generici during pregnancy.

Breastfeeding

The active substance in TOPIRAMATO DOC Generici (topiramate) passes into breast milk. Effects have been observed in infants breastfed by mothers taking this medicine, including diarrhoea, drowsiness, irritability, and poor weight gain. Therefore, your doctor will discuss with you whether to discontinue breastfeeding or to discontinue/abstain from treatment with TOPIRAMATO DOC Generici, taking into account the importance of the medicine to the mother and the potential risk to the infant.

Breastfeeding mothers taking TOPIRAMATO DOC Generici should inform their doctor as soon as possible if the baby shows any unusual symptoms.

Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Dizziness, tiredness, and vision problems may occur during treatment with TOPIRAMATO DOC Generici. Do not drive or operate tools or machinery without first discussing this with your doctor.

3. How to take TOPIRAMATE DOC Generics

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

• Your doctor will usually start you on a low dose of TOPIRAMATE DOC Generics and then gradually increase it until the best dose for you is reached.
• The tablets of TOPIRAMATE DOC Generics must be swallowed whole. Avoid chewing the tablets, as they may leave a bitter taste.
• TOPIRAMATE DOC Generics can be taken before, during, or after a meal. Drink plenty of fluids throughout the day to reduce the risk of kidney stone formation while taking TOPIRAMATE DOC Generics.

If you take more TOPIRAMATE DOC Generics than you should

• Contact a doctor immediately. Take the medicine package with you.
• You may feel drowsy, tired, or less alert; experience lack of coordination; have difficulty speaking or concentrating; suffer from blurred or double vision; feel dizzy due to low blood pressure; feel depressed or agitated; have abdominal pain, or experience seizures. If you are taking other medicines together with TOPIRAMATE DOC Generics, an overdose may occur.

If you forget to take TOPIRAMATE DOC Generics

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

If you stop taking TOPIRAMATE DOC Generics
Do not stop taking this medicine unless your doctor tells you to. Your symptoms may return. If your doctor decides to stop this medicine, your dose may be gradually reduced over several days.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately, or seek medical help, if you experience the following
side effects:
Very common (may affect more than 1 in 10 people)
Depression (new or worsening)
Common (may affect up to 1 in 10 people)
Seizures
Anxiety, irritability, mood changes, confusion, disorientation
Problems with concentration, slowed thinking, memory loss (new onset, sudden change, or increased severity)
Kidney stones, frequent need to urinate, or pain when urinating
Uncommon (may affect up to 1 in 100 people)
Increased levels of acid in the blood (may cause breathing difficulties including shortness of breath, loss of appetite, nausea, vomiting, excessive tiredness, and rapid or irregular heartbeat)
Reduced or absent sweating (particularly in young children exposed to high temperatures)
Thoughts of severe self-harm, attempts at severe self-harm
Loss of part of the visual field
Rare (may affect up to 1 in 1,000 people)
Glaucoma – fluid retention in the eye causing increased eye pressure, eye pain, and vision loss
Difficulty thinking, remembering information, or solving problems, reduced alertness or awareness, feeling very drowsy and lacking energy – these symptoms may be signs of high blood ammonia levels (hyperammonaemia), which can lead to changes in brain function (hyperammonaemic encephalopathy)
Other side effects include those listed below. If any of these worsen, inform your doctor or pharmacist:
Very common (may affect more than 1 in 10 people)
Stuffy, runny nose or sore throat
Tingling, pain, and/or numbness in various parts of the body
Drowsiness, tiredness
Dizziness
Nausea, diarrhoea
Weight loss
Common (may affect up to 1 in 10 people)
Anaemia (reduced blood count)
Allergic reaction (such as rash, redness, itching, facial swelling, hives)
Loss of appetite, decreased appetite
Aggression, agitation, anger, abnormal behaviour
Difficulty falling asleep or staying asleep
Problems with speech or language disorders, difficulty articulating words
Clumsiness or lack of coordination, feeling unsteady when walking
Reduced ability to complete routine tasks
Reduced, lost, or absent sense of taste
Involuntary tremors or shaking; rapid uncontrolled eye movements
Vision disturbances, such as double vision, blurred vision, reduced vision, difficulty focusing
Feeling dizzy (vertigo), ringing in the ears, ear pain
Shortness of breath
Cough
Nosebleeds
Fever, feeling unwell, weakness
Vomiting, constipation, abdominal pain or discomfort, indigestion, stomach or intestinal infection
Dry mouth
Hair loss
Itching
Joint pain or swelling, muscle spasms or cramps, muscle pain or weakness, chest pain
Weight gain
Uncommon (may affect up to 1 in 100 people)
Reduced platelet count (blood cells that help stop bleeding), reduced white blood cells (which help protect against infections), low blood potassium levels
Increased liver enzymes, increased eosinophils (a type of white blood cell) in the blood
Swelling of the glands in the neck, armpits, or groin
Increased appetite
Elevated mood
Hearing, seeing, or sensing things that are not there, severe mental disturbances (psychosis)
Lack of emotional expression or experience, unusual suspiciousness, panic attacks
Problems with reading, language disorders, writing difficulties
Restlessness, hyperactivity
Slowed thinking, reduced wakefulness or alertness
Reduced or slowed body movements, involuntary abnormal or repetitive muscle movements
Fainting
Abnormal sense of touch, altered sensation to touch
Impaired, distorted, or absent sense of smell
Unusual perception or sensation that may precede a migraine attack or a certain type of seizure
Dry eyes, light sensitivity, involuntary eye contractions, excessive tearing
Reduced or lost hearing, hearing loss in one ear
Slow or irregular heartbeat, awareness of your heartbeat in your chest
Low blood pressure, low blood pressure upon standing (as a result of taking topiramate, some people may feel faint, dizzy, or may faint when standing up or sitting up quickly)
Hot flushes, feeling of warmth
Pancreatitis (inflammation of the pancreas)
Excessive passage of intestinal gas, heartburn, feeling of fullness or abdominal bloating
Bleeding gums, increased salivation, reduced saliva, bad breath
Excessive fluid intake, thirst
Skin discoloration
Muscle stiffness, flank pain
Blood in urine, urinary incontinence (lack of control), urgent need to urinate, flank or kidney pain
Difficulty achieving or maintaining an erection, sexual dysfunction
Flu-like symptoms
Cold fingers and toes
Feeling of drunkenness
Learning difficulties
Rare (may affect up to 1 in 1,000 people)
Abnormally elevated mood
Loss of consciousness
Blindness in one eye, temporary blindness, night blindness
Lazy eye
Swelling of the eyes and swelling around the eyes
Numbness, tingling, and colour changes in fingers and toes (turning white, blue, then red) when exposed to cold
Liver inflammation, liver failure
Stevens-Johnson syndrome, a potentially life-threatening condition that may present with sores in multiple mucosal sites (such as mouth, nose, and eyes), skin rash, and blisters
Altered body odour
Problems in arms and legs
Kidney disorders
Side effects with unknown frequency (frequency cannot be estimated from available data)
Maculopathy, a disease of the macula, the small part of the retina where vision is sharpest. If you notice a change or decrease in vision, contact your doctor.
Toxic epidermal necrolysis, a potentially life-threatening condition related to Stevens-Johnson syndrome but more severe, characterized by widespread blistering and peeling of the outer layers of the skin (see rare side effects).
Children
Side effects in children are generally similar to those seen in adults, but the following side effects may be more common in children than in adults:
Problems with concentration
Increased blood acid levels
Thoughts of severe self-harm
Tiredness
Decreased or increased appetite
Aggression, abnormal behaviour
Difficulty falling asleep or staying asleep
Feeling unsteady when walking
Feeling unwell
Reduced blood potassium levels
Lack of emotional expression and/or feeling
Excessive tearing
Slow or irregular heartbeat
Other side effects that may occur in children are:
Common (may affect up to 1 in 10 people)
Feeling of spinning (dizziness)
Vomiting
Fever
Uncommon (may affect up to 1 in 100 people)
Increased eosinophils (a type of white blood cell) in the blood
Hyperactivity
Feeling hot
Learning difficulties
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TOPIRAMATE DOC Generics

• Keep this medicine out of the sight and reach of children.
• Store below 25°C. Keep in the original packaging to protect the medicine from moisture.

Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What TOPIRAMATE DOC Generici contains

• The active substance is topiramate. Each tablet contains 25 mg, 50 mg, 100 mg or 200 mg of topiramate.
• The excipients are: methylcellulose (E461), sodium croscarmellose (E468), magnesium stearate (E470b), colloidal anhydrous silica (E551), hypromellose (E464), hydroxypropylcellulose (E463), macrogol and titanium dioxide (E171). The 50 mg and 100 mg tablets contain yellow iron oxide (E172) as a colouring agent. The 200 mg tablets contain red iron oxide (E172) as a colouring agent.

Description of the appearance of TOPIRAMATE DOC Generici and contents of the pack
Please check you are taking the correct medicine:

• TOPIRAMATE DOC Generici 25 mg tablets, each containing 25 mg, are white and round, with the imprint “APO” on one side and “TP 25” on the other.
• TOPIRAMATE DOC Generici 50 mg tablets, each containing 50 mg, are light yellow and round, with the imprint “APO” on one side and “TP 50” on the other.
• TOPIRAMATE DOC Generici 100 mg tablets, each containing 100 mg, are mustard-coloured and round, with the imprint “APO” on one side and “TP 100” on the other.
• TOPIRAMATE DOC Generici 200 mg tablets, each containing 200 mg, are reddish-brown and round, with the imprint “APO” on one side and “TP 200” on the other.

Pack sizes:
Tablets are available in blisters, in packs of 28 and 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
DOC Generici S.r.l
Via Turati 40
20121 Milan
Italy

Manufacturer responsible for batch release:
Apotex Nederland B.V.
Bio Science Park
Archimedesweg 2
2333 CN Leiden
The Netherlands

Lachifarma S.r.l. Laboratorio Chimico Salentino
S.S. 16 Zona industriale
73010 Zollino (Lecce)
Italy

For any further information about this medicinal product, please contact:
DOC Generici S.r.l.
Via Turati 40
20121 Milan
Italy

This patient information leaflet was last approved on