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Normon S.A. - Sapin

ANASTROZOLE NORMON
BISOPROLOL NORMON
DESLORATIDINE NORMON
ESCITALOPRAM NORMON
ESOMEPRAZOLE NORMON
ESTECINA Inj.
ESTECINA Tablets
FIXIM
GASTRIMUT
LAMOTRIGINE NORMON
LETROZOLE NORMON
LEVOFLOXACIN NORMON
LIDOCAINE 2% EPINEPHRINE NORMON
NORMOCEF
NORMOPRIL
PARACETAMOL NORMON
SIMVASTATIN NORMON
TOPAGAN

Forms and presentation
Topagan 25 mg: Film-coated Tablets: Box of 60.
Topagan 50 mg: Film-coated Tablets: Box of 60.
Topagan 100 mg: Film-coated Tablets: Box of 60.
Topagan 200 mg: Film-coated Tablets: Box of 60.

Composition
Topagan 25 mg: Each tablet contains: Topiramate: 25 mg. Excipients: Anhydrous lactose, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, colloidal silica, hypromellose, titanium dioxide, macrogol 6000.
Topagan 50 mg: Each tablet contains: Topiramate: 50 mg. Excipients: Anhydrous lactose, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, colloidal silica, hypromellose, titanium dioxide, macrogol 6000, yellow iron oxide.
Topagan 100 mg: Each tablet contains: Topiramate: 100 mg. Excipients: Anhydrous lactose, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, colloidal silica, hypromellose, titanium dioxide, macrogol 6000, yellow iron oxide.
Topagan 200 mg: Each tablet contains: Topiramate: 200 mg. Excipients: Anhydrous lactose, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, colloidal silica, hypromellose, titanium dioxide, macrogol 6000, red iron oxide.

Properties
Antiepileptics.

Indications
Topiramate tablets is indicated:
- For single-drug therapy in adults and children above 11 years of age recently diagnosed of epilepsy.
- For concomitant treatment with other medicines in adults and children from 2 years of age with a type of epileptic seizures called partial-onset or generalised tono-clonic seizures.
- For concomitant treatment with other medicines in adults and children for seizures associated with the epileptic syndrome called Lennox-Gastaut.
- As preventive treatment for migraine in adults.

Contraindications
Hypersensitivity to topimarate or to any of the other ingredients of this medicine.
Migraine prophylaxis in pregnancy and in women of childbearing potential if not using effective methods of contraception.

Precautions
Caution must be exercised in patients suffering from weight loss during treatment, in patients suffering from any liver or kidney disease, in susceptible patients to formation of kidney stones, this risk can be increased. An adequate fluid intake is important to reduce the risk of kidney stones to occur.
Topiramate can reduce bicarbonate blood levels.
Topiramate can cause a reduction in sweating (oligohydrosis) that can be serious, as it causes a significant body temperature increase during exercise and exposure to hot environments. Most of these cases have been described in children.
Topagan must be discontinued gradually for the purpose of reducing the risk of increasing the frequency of seizures.
This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medication..

Drug interactions
Do not take topiramate tablets with: saquinavir, acetozolamide and triamterene, calcium salts and vitamin C.
Caution must be exercised when using topiramate together with any of the following medicines: Antiepileptics (phenytoin, lamotrigine and carbamazepine, valproic acid, phenobarbital, and primidone), hypoglycemic agents (metformin and pioglitazone), CNS depressants, hydrochlorothiazide, digoxin, dihydroergotamine and sumatriptan, haloperidol, propranolol, pizotifen.
Concomitant administration of topiramate with oral contraceptives can reduce their contraceptive effect.
Taking Topagan with food and drink: Do not take alcohol drinks during treatment, as the effects on the CNS system can increase. Topiramate does not interact with food; therefore, it can be administered with food or without it.

Ability to drive and use machine
There may be dizziness, fatigue and visual disturbances during treatment with Topagan. It’s advised not to drive vehicles, nor handle dangerous machinery until the response to the treatment is known.

Pregnancy and lactation
Like any other antiepileptic drug, there is a risk of damage to the fetus if Topagan is used during pregnancy. Topagan should not be used during pregnancy and breast-feeding.

Side effects
When taking topiramate together with other antiepileptics or alone, the most common side effects were mainly those related to the CNS

Blood and lymphatic system disorders:
Uncommon: white blood cell count reduction.

Endocrine disorders:
Rare: Inflammation of the pancreas.

Metabolism and nutrition disorders:
Common: weight loss.
Rare: metabolic acidosis

Nervous system disorders:
Common: drowsiness, light-headedness, nervousness, fatigue, headache, movement disorders, coordination problems, abnormal gait, slow movements, tingling and muscle numbness, speech and language disorders, concentration and attention difficulties, memory disorders, mood disorders, aggressive reactions, depression, confusion, anorexia, hyperkinesis.
Uncommon: agitation, apathy, emotional disorders, intellectual function disorders, hallucinations.

Psychiatric disorders:
Very rare: suicidal ideas, suicidal attempts, suicide committed.

Eye disorders:
Common: abnormal vision, double vision, involuntary eye movement.
Very rare: increased eye pressure, pain in the eyes, myopia.

Vascular disorders:
Very rare: blood clotting.

Gastrointestinal disorders:
Common: nausea, abdominal pain, hypersalivation.

Hepatobiliary disorders:
Very rare: hepatitis, liver insufficiency, liver enzyme increase.

Skin and SC tissue disorders:
Rare: reduction or absence of sweating, particularly in children.
Very rare: skin and mucosal blisters (though most of these reactions were reported in patients receiving topiramate and other medicines associated with this type of reactions).

Renal and urinary disorders:
Uncommon: formation of stones in the kidney.

General disorders and administration site conditions:
Common: taste disturbances, lack of appetite.

 
Dosage and administration
Topiramate tablets are taken by oral route, with or without food, with an adequate amount of fluid. Topagan tablets must not be broken. 
The treatment with topiramate should be discontinued progressively to minimise the risk of increasing the frequency of seizures. 
Epilepsy: It is advisable both in adults and children to start treatment with topiramate with the lowest dose and increase it progressively until the effective dose is obtained. 
1) Concomitant treatment with topiramate and other antiepileptics 
- Adults: The treatment will be started with 25-50 mg every night for 1 week. After this first week of treatment, at weekly or fortnightly intervals, the dose will be increased from 25-50 mg and will be administered divided into 2 doses. The most common total daily dose ranging from 200-400 mg a day, divided into 2 doses; however, some patients may require higher doses. Administration of single daily doses may be effective for some patients. 
- Children aged 2 years or older: The treatment will start with doses of 1-3 mg/kg/day, every night for one week. 
After this first week of treatment, at weekly or fortnightly intervals, the dose will be increased from 1-3 mg/kg/day, and will be administered divided into 2 doses. The most common total daily dose ranges from 5-9 mg/kg/day, divided into 2 doses. 
2) Treatment with topiramate alone 
- Adults: The treatment is started with 25 mg every night for one week. After this first week of treatment, at weekly or fortnightly intervals, the dose will be increased from 25-50 mg and will be administered divided into 2 doses. The most common total daily dose is 100 mg a day, divided into 2 doses; however, some patients can require higher doses. 
- Children older than 11 years of age: The treatment will start with doses of 0.5-1 mg/kg/day, every night for 1 week. After this first week of treatment, at weekly or fortnightly intervals, the dose will be increased from 0.5-1 mg/kg/day, and will be administered divided into 2 doses. The most common total daily dose ranges from 3-6 mg/kg/day, divided into 2 doses. 
Migraine: The treatment is started with 25 mg every night for 1 week. After this first week of treatment, at one-week intervals, the dose will be increased by 25 mg/day. The recommended total daily dose is 100 mg a day, divided into 2 doses. 
 
Overdosage
The symptoms and signs can include: seizures, drowsiness, speech disorders, blurred vision, double vision, impaired mental activity, lethargy, abnormal coordination, stupor, low blood pressure, abdominal pain, agitation, light-headedness and depression. 
 
Storage conditions
Do not store above 30ºC. Keep the blister perfectly close to protect it from humidity. 
 
Origin: Spain
Laboratories: Normon
Distributor: Droguerie Phenicia
Year of submission: 2012
Number & Year of Registration
25mg: 96888/2013
50mg: 96889/2013
100mg: 96890/2013
200mg: 96891/2013