Topamax - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf life and Storage Composition and pharmaceutical form

Active ingredients: Topiramate

Topamax 25, 50, 100, 200 mg film-coated tablets

Topamax package inserts are available for pack sizes:
  • Topamax 25, 50, 100, 200 mg film-coated tablets
  • Topamax 15, 25 mg hard capsules

Indications Why is Topamax used? What is it for?

Topamax belongs to a group of medicines called 'antiepileptic medicines'. It is employed:

  • on its own for the treatment of seizures in adults and children over 6 years of age
  • with other medicines to treat seizures in adults and children from 2 years of age
  • to prevent migraines in adults

Contraindications When Topamax should not be used

Do not take Topamax

  • if you are allergic to topiramate or any of the other ingredients of this medicine (listed in section 6).
  • for the prevention of migraine if you are pregnant or of childbearing age but do not use adequate contraception (see section "pregnancy and breastfeeding" for more information).

If you are not sure if any of the above conditions apply to you, talk to your doctor or pharmacist before using Topamax.

Precautions for use What you need to know before you take Topamax

Consult your doctor or pharmacist before taking Topamax if:

  • have kidney problems, especially kidney stones, or are undergoing kidney dialysis
  • have a history of blood and body fluid abnormalities (metabolic acidosis)
  • have liver problems
  • have eye problems, especially glaucoma
  • has growth problems
  • your diet is high in fat (ketogenic diet)
  • you are pregnant or may become pregnant (for more information see the "pregnancy and breastfeeding" section).

If you are not sure if any of the above conditions apply to you, talk to your doctor or pharmacist before having treatment with Topamax.

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

You should also talk to your doctor before taking any topiramate medicines that are given to you as an alternative to Topamax.

You may lose weight using Topamax, so your weight should be checked regularly while taking this medicine. If you lose too much weight or if a child using the medicine does not gain enough weight, consult your doctor.

A small number of people treated with antiepileptic medicines such as Topamax have had thoughts of harming or killing themselves. In case you have these kinds of thoughts at any time, contact your doctor immediately.

Interactions Which drugs or foods may change the effect of Topamax

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Topamax and some other medicines can interact with each other. Sometimes the dose of some of the medicines you are taking or Topamax will need to be adjusted.

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

  • other medicines that impair or reduce muscle thinking, concentration, or coordination (e.g. central nervous system depressant medicines such as muscle relaxants and sedatives)
  • birth control pill. Topamax may reduce the effectiveness of the birth control pill.

Tell your doctor if you notice a change in your menstrual bleeding while taking the birth control pill and Topamax.

Keep a list of all the medicines you take. Show this list to your doctor or pharmacist before you start taking a new medicine.

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

If you are not sure if any of the above conditions apply to you, talk to your doctor or pharmacist before using Topamax.

Topamax with food and drink

You can take Topamax with or between meals. Drink plenty of fluids throughout the day when taking Topamax to prevent kidney stones from forming. You should avoid drinking alcohol while being treated with Topamax.

Warnings It is important to know that:

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will decide if you should take Topamax. As with other antiepileptic medicines, there is a risk of harm to the fetus if Topamax is used in pregnancy. Make sure you are clear about the risks and benefits of using Topamax for epilepsy during pregnancy.

You should not take Topamax for migraine prevention if you are pregnant or of childbearing age and do not use effective contraception.

Mothers who are breastfeeding when taking Topamax should tell their doctor as soon as possible if their baby experiences anything unusual.

Driving and using machines

Dizziness, tiredness and vision problems may occur during treatment with Topamax. Do not drive or use any tools or machines without first talking to your doctor.

Important information about some of the ingredients of Topamax

If you have been told by your doctor that you have an intolerance to sugars, contact your doctor before taking this medicine.

Dose, Method and Time of Administration How to use Topamax: Posology

Always take this medicine exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.

  • Your doctor will usually give you a low dose of Topamax and then slowly increase it until you find the best dose for you.
  • Topamax tablets should be swallowed whole. Avoid chewing the tablets as they can leave a bitter taste.
  • Topamax can be taken before, during or after a meal. Drink plenty of water throughout the day to avoid kidney stones while taking Topamax.

Overdose What to do if you have taken too much Topamax

If you take more Topamax than you should

  • Consult a doctor immediately. Take the medicine pack with you.
  • He may feel sleepy, tired, or be less alert; lose coordination; having difficulty speaking or concentrating; having double or blurred vision; get dizzy caused by low blood pressure; feeling depressed or agitated; or have abdominal pain, or seizures.

If you are taking other medicines together with Topamax, an overdose may occur.

If you forget to take Topamax

  • If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue as usual. 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 Topamax

Do not stop taking this medicine unless your doctor tells you to. Your symptoms may recur. If your doctor decides to stop this medicine, your dose may be gradually decreased over the course of a few days.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Side Effects What are the side effects of Topamax

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor or see your doctor immediately if you experience any of the following side effects:

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

  • Depression (new or worsening)

Common (may affect less than 1 in 10 patients)

  • Epileptic crisis
  • Anxiety, irritability, mood changes, confusion, disorientation
  • Problems concentrating, slow thinking, memory loss, memory problems (new onset, sudden change or increase in severity)
  • Kidney stone, frequent or painful urination

Uncommon (may affect less than 1 in 100 patients)

  • Increased acid level in the blood (can cause breathing disturbances including shortness of breath, loss of appetite, nausea, vomiting, excessive tiredness and fast or irregular heartbeats)
  • Decrease or loss of sweating
  • Thoughts of severe self-harm, attempted severe self-harm
  • Loss of part of the visual field

Rare (may affect less than 1 in 1000 patients)

  • Glaucoma which is a retention of fluid in the eye resulting in increased pressure in the eye, pain or decreased vision

Other side effects include the following, if these get worse consult your doctor or pharmacist:

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

  • Stuffed, runny or sore throat
  • Tingling, pain and / or numbness of various parts of the body
  • Drowsiness, tiredness
  • Dizziness
  • Nausea, diarrhea
  • Weight loss

Common (may affect less than 1 in 10 patients)

  • Anemia (low red blood cell count)
  • Allergic reaction (such as rash, redness, itching, swelling of the face, hives)
  • Loss of appetite, decreased appetite
  • Aggression, agitation, anger
  • Difficulty falling asleep or staying asleep
  • Speech problems or disorders, difficulty speaking
  • Clumsiness or loss of coordination, feeling of unsteadiness when walking
  • Decreased ability to perform routine activities
  • Decreased, lost, or no sense of taste
  • Involuntary tremors or shaking: rapid, uncontrollable eye movements
  • Visual disturbances such as double vision, blurred vision, decreased vision, difficulty focusing
  • Sensation of spinning (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 twitching, muscle aches or weakness, chest pain
  • Weight gain

Uncommon (may affect less than 1 in 100 patients)

  • Decrease in platelets (blood cells that help stop bleeding), decrease in white blood cells, which help protect against infections, decrease in blood potassium levels
  • Increase in liver enzyme levels, increase in eosinophils (a type of white blood cell) in the blood
  • Swelling of the glands in the neck, armpits or groin
  • Increased appetite
  • Mood improvement
  • Hearing, seeing or hearing things that are not there, severe mental disorders (psychosis)
  • Not showing and / or feeling emotions, unusual suspiciousness, panic attack
  • Problems with reading, speech disorders, writing problems
  • Restlessness, hyperactivity
  • Slowed thinking, decreased wakefulness or alertness
  • Slowed or decreased body movements, abnormal or repetitive involuntary muscle movements
  • Fainting
  • Abnormal or impaired sense of touch
  • Impaired, distorted or absent sense of smell
  • Unusual sensation or sensation that may precede a migraine or a certain type of seizure
  • Dry eyes, sensitivity of the eyes to light, twitching of the eyelids and tearing
  • Decreased or loss of hearing, loss of hearing in one ear
  • Slow or irregular heartbeat, feel your own beating in the chest
  • Low blood pressure, decrease in blood pressure when standing up (as a result, some people who take Topamax may feel faint, have a spinning head or may pass out when standing up or sitting up suddenly)
  • Hot flashes, feel hot
  • Pancreatitis (inflammation of the pancreas)
  • Excessive passing of gas or air, heartburn, feeling of fullness or bloating
  • Bleeding gums, increased saliva, loss of saliva, bad breath
  • Excessive fluid intake, thirst
  • Skin discoloration
  • Muscle stiffness, flank pain
  • Blood in your urine, incontinence (loss of control) of your urine, urgent need to pass urine, pain in your side or kidney
  • Difficulty getting or maintaining an erection, sexual dysfunction
  • Flu-like symptoms
  • Cold fingers and feet
  • Feeling of intoxication
  • Learning disabilities

Rare (may affect less than 1 in 1000 patients)

  • abnormally elevated mood
  • Loss of consciousness
  • Blindness in one eye, temporary blindness, night blindness
  • Lazy eye
  • Swelling in and around the eyes
  • Numbness, tingling, and color change (white, blue, and then red) of the fingers and toes when exposed to cold
  • Inflammation of the liver, liver failure
  • Stevens-Johnson syndrome, a life-threatening condition that can manifest itself with ulcers in multiple mucous sites (such as the mouth, nose and eyes), a rash and blisters
  • Abnormal skin odor
  • Discomfort in the arms or legs
  • Kidney disorder

Not known (frequency cannot be estimated from the 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 your vision you should contact your doctor
  • Toxic epidermal necrolysis, a life-threatening condition related, albeit more serious, to Steven-Johnson syndrome characterized by widespread blistering and flaking of the outer layers of the skin (see rare side effects)

Children and adolescents

Side effects in children are generally similar to those seen in adults. However, some side effects occur more frequently in children and / or may be more serious in children than in adults. Side effects that may be more serious include decreased or loss of sweating and an increase in the level of acid in the blood. Side effects that may occur more frequently in children include upper respiratory tract diseases.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

Expiry and Retention

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton / bottle. The expiry date refers to the last day of that month.

Do not store above 25 ° C. Store the tablets in the original package (blister or bottle) in order to protect from moisture. Keep the bottle tightly closed to protect the tablets from moisture.

Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Composition and pharmaceutical form

What Topamax contains

The active ingredient is topiramate.

  • Each Topamax tablet contains 25, 50, 100, 200 mg of topiramate.

The other ingredients of Topamax are listed below.

Nucleus:

lactose monohydrate

pregelatinised maize starch

microcrystalline cellulose

sodium starch glycolate (type A)

magnerium stearate

Coating:

OPADRY® white, yellow, pink1, carnauba wax

1OPADRY® contains:

hypromellose

macrogol

polysorbate 80

and as dyes, titanium dioxide E171 (all strengths), yellow iron oxide E172 (50 and 100 mg) and red iron oxide E172 (200 mg).

What Topamax looks like and contents of the pack

  • 25 mg tablet: white, round, 6 mm in diameter, engraved with "TOP" on one side and "25" on the other.
  • 50 mg tablet: light yellow, round, 7 mm in diameter, engraved with "TOP" on one side and "50" on the other.
  • 100 mg tablet: yellow, round, 9 mm in diameter, engraved with "TOP" on one side and "100" on the other.
  • 200 mg tablet: salmon pink, round, 10 mm in diameter, engraved with "TOP" on one side and "200" on the other.

Opaque plastic bottle with tamper evident closure, containing 20, 28, 30, 50, 56, 60, 100 or 200 (2x100) tablets. ; In each bottle, there is a desiccant container which should not be swallowed.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

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