Topiramate Accord Healthcare 25Mg, 50Mg, 100Mg and 200Mg Film-Coated Tablets (Topiramate)

Home , Prevention of migraines

Package leaflet: Information for the user Topiramate Accord Healthcare 25mg, 50mg, 100mg and 200mg Film-coated Tablets (Topiramate)

Read all of this leaflet carefully before you start Topiramate tablets with food, drink and alcohol taking this medicine because it contains important You can take Topiramate tablets with or without food. To information for you. prevent kidney stones whilst being treated with Topiramate • Keep this leaflet. You may need to read it again. tablets, drink plenty of fluids during the day. You should • If you have any further questions, ask your doctor or avoid drinking alcohol when taking Topiramate tablets. pharmacist. Pregnancy and breast-feeding • This medicine has been prescribed for you only. Do Pregnancy not pass it on to others. It may harm them, even if Migraine prevention: their signs of illness are the same as yours. Topiramate tablets can harm an unborn baby. You must • If you get any side effects, talk to your doctor or not take Topiramate tablets if you are pregnant. You must pharmacist. This includes any possible side effects not not take Topiramate tablets for migraine prevention if you listed in this leaflet. See section 4. are a woman of childbearing potential unless you are using • The full name of this medicine is Topiramate Accord effective contraception. Talk to your doctor about the best Healthcare 25mg, 50mg, 100mg and 200mg kind of contraception and whether Topiramate tablets Film-coated Tablets but within the leaflet it will be are suitable for you. Before the start of treatment with referred to as Topiramate tablets. Topiramate tablets, a pregnancy test should be performed. Treatment of epilepsy: If you are a woman of childbearing potential you should What is in this leaflet: talk to your doctor about other possible treatments instead 1 What Topiramate tablets are and what they of Topiramate tablets. If the decision is made to take are used for Topiramate tablets, you should use effective contraception. 2 What you need to know before you take Talk to your doctor about the best kind of contraception to use while you are taking Topiramate tablets. Before the Topiramate tablets start of treatment with Topiramate tablets a pregnancy test 3 How to take Topiramate tablets should be performed. 4 Possible side effects 5 How to store Topiramate tablets Talk to your doctor if you wish to become pregnant. As 6 Contents of the pack and other information with other antiepileptic medicines, there is a risk of harm to the unborn child if Topiramate tablets is used during pregnancy. Make sure you are very clear about the risks and the benefits of taking Topiramate tablets for epilepsy 1 What Topiramate tablets are and what they during pregnancy. are used for • If you take Topiramate tablets during pregnancy, your Topiramate belongs to a group of medicines called baby has a higher risk for birth defects, particularly, cleft antiepileptic medicines. It is used: lip (split in the top lip) and cleft palate (split in the roof of • alone to treat seizures in adults and children over age 6 the mouth). Newborn boys may also have a malformation • with other medicines to treat seizures in adults and of the penis (hypospadia). These defects can develop children aged 2 years and above early in pregnancy, even before you know you are • to prevent migraine headaches in adults. pregnant. • If you take Topiramate tablets during pregnancy, your 2 What you need to know before you take baby may be smaller than expected at birth. Talk to Topiramate tablets your doctor if you have questions about this risk during Do not take Topiramate tablets pregnancy. • if you are allergic to topiramate or any of the other • There may be other medicines to treat your condition ingredients of this medicine (listed in section 6). that have a lower risk of birth defects. • for migraine prevention do not take if you are pregnant • Tell your doctor straight away if you become pregnant or if you are a woman of childbearing potential unless you while taking Topiramate tablets. You and your doctor are using effective contraception (see ‘Pregnancy and should decide if you will continue to take Topiramate breast-feeding’ for further information). You should talk to tablets while you are pregnant. your doctor about the best kind of contraception to use while you are taking Topiramate tablets. Breast-feeding The active substance in Topiramate tablets (topiramate) Warnings and precautions passes into human milk. Effects have been seen in Talk to your doctor or pharmacist before taking breastfed babies of treated mothers, including diarrhoea, Topiramate tablets if you feeling sleepy, feeling irritable, and poor weight gain. • have, or have a family history of kidney stones or too Therefore, your doctor will discuss with you whether you much calcium in the urine abstain from breast-feeding or whether to abstain from • have other kidney problems, or are having kidney treatment with Topiramate tablets. Your doctor will take dialysis into account the importance of the medicine to the mother and the risk for the baby. • have a history of blood and body fluid abnormality

(metabolic acidosis) Mothers who breastfeed while taking Topiramate tablets • have liver problems must tell the doctor as soon as possible if the baby • have eye problems, especially glaucoma experiences anything unusual. • have a growth problem • are on a high fat diet (ketogenic diet) Driving and using machines • are taking Topiramate tablets to treat epilepsy and you Dizziness, tiredness and vision problems may occur whilst are pregnant or a woman of childbearing potential taking Topiramate tablets. Do not drive or use any tools or (see section ‘Pregnancy and breast-feeding’ for further machines without talking to your doctor first. information). Topiramate tablets contain lecithin (soya oil) If you are not sure if any of the above applies to you, talk to Topiramate 50mg, 100mg and 200mg tablets contain your doctor or pharmacist before lecithin (soya oil). If you are allergic to peanuts or soya, do using Topiramate tablets. not use this medicinal product.

It is important that you do not stop taking your medicine This medicine contains less than 1 mmol sodium without first consulting your doctor. (23mg) per film-coated tablet, that is to say essentially ‘sodium-free’. You should also talk to your doctor before taking any other medicine containing topiramate that is given to you as an 3 How to take Topiramate tablets alternative to Topiramate tablets. Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not You may experience weight loss while taking Topiramate sure. tablets. Therefore, your weight should be checked regularly Your doctor will usually start you on a low dose and slowly when using this medicine. If you are losing too much increase your dose until the best dose is found. weight or if a child using this medicine is not gaining enough weight, you should consult your doctor. The recommended dose is If you take Topiramate tablets only for epilepsy You should drink plenty of fluids while taking Topiramate • Adults – starting dose of 25mg at night. The dose will tablets, especially prior to and during activities such as be slowly increased to a maintenance dose, usually 100- exercise or being exposed to warm temperatures, as this 200mg a day in 2 divided doses. Maximum dose of 500mg may reduce the risk of heat-related side effects. a day in 2 divided doses. • Children over 6 years of age – starting dose of 0.5-1mg A small number of people being treated with anti-epileptic per kg of body weight at night increasing slowly to a medicines such as Topiramate tablets have had thoughts maintenance dose, usually 100mg a day. of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor. If you take Topiramate tablets with another epilepsy medicine Topiramate tablets may in rare cases cause high levels of • Adults – starting dose of 25-50mg at night. The dose will ammonia in the blood (seen in blood tests) which can lead be slowly increased to a maintenance dose, usually 200- to a change in brain function, especially if you are also 400mg a day in 2 divided doses. taking a medicine called valproic acid or sodium valproate. Since this may be a severe condition, tell your doctor • Children over 2 years of age – starting dose of 1-3mg immediately if the following symptoms occur (see also per kg of body weight at night increasing slowly to a section 4 ‘Possible side effects’): maintenance dose, usually 5-9mg per kg of body weight a day in 2 divided doses. • difficulty thinking, remembering information, or solving problems Prevention of migraines • being less alert or aware • Adults – starting dose of 25mg at night. The dose will be • feeling very sleepy with low energy slowly increased to a maintenance dose of 100mg a day At higher doses of Topiramate tablets, the risk of in 2 divided doses. developing these symptoms may increase. • Children – Not recommended for use in children. Other medicines and Topiramate tablets Swallow whole. Do not chew. Take with or without food. Tell your doctor or pharmacist if you are taking, have To prevent kidney stones while taking Topiramate tablets, recently taken or might take any other medicines. drink plenty of fluids during the day. Topiramate and certain other medicines can affect each other. Sometimes the dose of some of your other If you take more Topiramate tablets than you medicines or Topiramate tablets will have to be adjusted. should Especially, tell your doctor or pharmacist if you are taking: See a doctor right away. Take the medicine pack with you. • other medicines that impair or decrease your thinking, Signs and symptoms of overdose may include: feeling concentration, or muscle coordination (e.g. central sleepy or tired, abnormal body movements, problems nervous system depressant medicines such as muscle standing and walking, feeling dizzy due to low blood relaxants and sedatives) pressure, fits, double or blurred vision, changes in thinking • birth control pills. Topiramate may make these pills and alertness, loss of consciousness, speech problems, less effective. You should talk to your doctor about the changes in mood or behaviour (including anger or best kind of contraception to use while you are taking depression), stomach pain. Topiramate tablets. If your menstrual bleeding changes, Overdose can happen if you are taking other medicines you have breakthrough bleeding or spotting, tell your together with Topiramate tablets. doctor • other antiepileptic medicines (e.g. carbamazepine or If you forget to take Topiramate tablets phenytoin, which can reduce the effect of topiramate) If you forget to take a dose, take it as soon as you • risperidone, lithium, amitriptyline, venlafaxine, remember it. However, if it is almost time for your next moclobamide, imipramine, St John’s Wort (for dose, skip the missed dose and continue as usual. If you depression) miss two or more doses, contact your doctor. Do not take a • warfarin (used to thin the blood) double dose to make up for a forgotten dose. • hydrochlorothiazide, propranolol, diltiazem (for angina and high blood pressure) If you stop taking Topiramate tablets • metformin, pioglitazone, glibenclamide (antidiabetic Do not stop taking this medicine, even if you feel better, medicines) unless your doctor tells you to as your symptoms may • flunarazine (for migraines) return. If your doctor decides to stop this medication, your • digoxin (for heart problems) dose may be decreased gradually over a few days. • haloperidol (for mental health problems) If you have any further questions on the use of this • proguanil (for malaria) medicine, ask your doctor or pharmacist. • omeprazole (for stomach acid).

Continued top of next column Continued on next page BBBA9667

Topiramate All strengths Film-coated Tablets PIL - UK

approved for print/date Item number: BBBA9667 Colours Non Printing Colours 1. Black 1. Originator: M.Doak Dimensions: 190x600 2. 2. Origination Date: 11/11/2020 Min Body Text Size: 9pt Revision Date: Supplier: Teva Bulgaria Dupnitsa 3. 3. Revised By: 4. 5. Proof Round Technical Date sent: 11/11/2020 6. 01 Approval Date received: 18/11/2020 [email protected]

Cartons and label leaflets only (labels only when specified) German GTIN 14 (incorporating PZN): N/A * Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 7 No changes are permitted by any 3rd party other than added notes and mark ups for required changes. 12.02.2020 4 Possible side effects Children and adolescents Like all medicines, this medicine can cause side effects, The side effects in children are generally similar to those although not everybody gets them. seen in adults, but the following side effects may be more common in children than adults: Tell your doctor, or seek medical attention immediately Problems with concentration, increased acid level in the if you have the following side effects: blood, having thoughts of serious self-harm, tiredness, Very common (may affect more than 1 in 10 people) decreased or increased appetite, aggression, abnormal • Depression (new or worse). behaviour, difficulty falling or staying asleep, feeling of unsteadiness when walking, not feeling well, decrease in Common (may affect up to 1 in 10 people) potassium level in the blood, showing and/or feeling no • Allergic reaction (such as skin rash, redness, itching, facial emotion, watery eyes, slow or irregular heartbeat swelling, hives) • Seizures (fits) Other side effects that may occur in children are: • Anxiety, irritability, changes in mood, confusion, Common (may affect up to 1 in 10 people) disorientation Sensation of spinning (vertigo), vomiting, fever. • Problems with concentration, slowness of thinking, loss of memory, problems with memory (new onset, sudden Uncommon (may affect up to 1 in 100 people) change or increased severity) Increase in eosinophils (a type of white blood cell) in the • Kidney stone, frequent or painful urination. blood, hyperactivity, feeling warm, learning disability.

Uncommon (may affect up to 1 in 100 people) Reporting of side effects • Increased acid level in the blood (may cause troubled If you get any side effects, talk to your doctor, pharmacist breathing including shortness of breath, loss of appetite, or nurse. This includes any possible side effects not listed in nausea, vomiting, excessive tiredness, and fast or uneven this leaflet. You can also report side effects directly via the heart beats) Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or • Decreased or loss of sweating (particularly in young search for MHRA Yellow Card in the Google Play or Apple children who are exposed to high temperatures) App Store. • Having thoughts of serious self-harm, trying to cause serious self-harm By reporting side effects you can help provide more • Loss of part of the field of vision. information on the safety of this medicine. • Pancreatitis (inflammation of the pancreas) 5 How to store Topiramate tablets Rare (may affect up to 1 in 1,000 people) Keep out of the sight and reach of children. • Glaucoma – blockage of fluid in eye causing increased Do not store above 25°C. pressure in the eye, pain, or decreased vision Do not use after the expiry date which is stated on the • Stevens-Johnson syndrome, a potentially life-threatening label. The expiry date refers to the last day of that month. condition that may present with sores in multiple Topiramate tablets which are supplied in bottles must be mucosal sites (such as the mouth, nose, and eyes), a skin used within 60 days of opening. There is a space provided rash, and blistering on the bottle for you to write the date that you opened • Difficulty thinking, remembering information, or solving them. problems, being less alert or aware, feeling very sleepy Do not throw away any medicines via wastewater or with low energy – these symptoms may be a sign of a household waste. Ask your pharmacist how to throw away high level of ammonia in the blood (hyperammonemia), medicines you no longer use. These measures will help which can lead to a change in brain function protect the environment. (hyperammonemic encephalopathy). 6 Contents of the pack and other information Not known (frequency cannot be estimated from the What Topiramate tablets contain available data) The active substance is topiramate. Each tablet contains • Maculopathy is a disease of the macula, the small spot in either 25mg, 50mg, 100mg or 200mg of topiramate. the retina where vision is keenest. You should call your The other ingredients are mannitol, starch (pregelatinised), doctor if you notice a change or decrease in your vision. cellulose (microcrystalline), croscarmellose sodium, silica • Toxic epidermal necrolysis, a life-threatening condition (colloidal anhydrous), magnesium stearate, polyvinyl related to, yet more severe than, Stevens-Johnson alcohol, titanium dioxide, macrogols (macrogol 3350), talc. syndrome, characterised by widespread blistering and The following ingredients are also in the: sloughing of the outer layers of the skin (see rare side • 50mg and 100mg tablets - lecithin (Soya) (E322) and iron effects). oxide yellow (E172). • Inflammation of the eye (uveitis) with symptoms such as • 200mg tablets - lecithin (Soya) (E322) and iron oxide red eye redness, pain, sensitivity to light, runny eyes, seeing (E172). small dots or getting blurred vision. What Topiramate tablets look like and contents of Other side effects include the following, if they get the pack serious, please tell your doctor or pharmacist: 25mg tablets are white, round, biconvex, tablets with 6mm Very common (may affect more than 1 in 10 people) diameter and engraved with the marking “V1”. • Stuffy, runny nose or sore throat 50mg tablets are light yellow, round, biconvex, tablets with • Tingling, pain and/or numbness of various body parts 8mm diameter and engraved with the marking “V3”. • Sleepiness, tiredness, dizziness, nausea, diarrhoea, 100mg tablets are yellow, round, biconvex, tablets with weight loss. 10mm diameter and engraved with the marking “V4”. 200mg tablets are salmon, oval, biconvex, tablets with 9.2- Common (may affect up to 1 in 10 people) 18.3mm dimensions and engraved with the marking “V5”. • Anaemia (low blood count) • Loss of appetite, decreased appetite Pack size of 60 tablets. • Aggression, agitation, anger, abnormal behaviour • Difficulty falling or staying asleep Marketing Authorisation Holder • Problems with speech or speech disorder, slurred speech Accord Healthcare Limited • Clumsiness or lack of coordination, feeling of Sage House unsteadiness when walking 319 Pinner Road • Decreased ability to complete routine tasks North Harrow • Decreased, loss of, or no sense of taste Middlesex • Involuntary trembling or shaking; rapid, uncontrollable HA1 4HF movements of the eyes United Kingdom • Visual disturbance, such as double vision, blurred vision, decreased vision, difficulty focusing Manufacturer • Sensation of spinning (vertigo), ringing in the ears, ear Balkanpharma-Dupnitsa AD pain 3 Samokovsko Schosse Str. • Shortness of breath Dupnitsa 2600 • Cough Bulgaria • Nose bleeds • Fever, not feeling well, weakness This leaflet was last revised in November 2020. • 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 up to 1 in 100 people) • Decrease in platelets (blood cells that help stop bleeding), decrease in white blood cells that help to protect you against infection, decrease in potassium level in the blood • Increase in liver enzymes, increase in eosinophils (a type of white blood cell) in the blood • Swollen glands in the neck, armpit, or groin • Increased appetite • Elevated mood • Hearing, seeing, or feeling things that are not there, severe mental disorder (psychosis) • Showing and/or feeling no emotion, unusual suspiciousness, panic attack • Problems with reading, speech disorder, problems with handwriting • Restlessness, hyperactivity • Slowed thinking, decreased wakefulness or alertness • Reduced or slow body movements, involuntary abnormal or repetitive muscle movements • Fainting • Abnormal sense of touch; impaired sense of touch • Impaired, distorted, or no sense of smell • Unusual feeling or sensation that may precede a migraine or a certain type of seizure • Dry eye, sensitivity of the eyes to light, eyelid twitching, watery eyes • Decreased or loss of hearing, loss of hearing in one ear • Slow or irregular heartbeat, feeling your heart beating in your chest • Low blood pressure, low blood pressure upon standing (consequently, some people taking Topiramate tablets may feel faint, dizzy, or may pass out when they stand up or sit up suddenly) • Flushing, feeling warm • Excessive passing of gas or wind, heartburn, abdominal fullness or bloating • Bleeding gums, increased saliva, drooling, breath odour • Excessive intake of fluids, thirst • Skin discolouration • Muscle stiffness, pain in side • Blood in urine, incontinence (lack of control) of urine, urgent desire to urinate, flank or kidney pain • Difficulty getting or keeping an erection, sexual dysfunction • Flu-like symptoms • Cold fingers and toes • Feeling drunk • Learning disability.

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 in and around the eyes • Numbness, tingling and colour change (white, blue then red) in fingers and toes when exposed to the cold • Inflammation of the liver, liver failure • Abnormal skin odour • Discomfort in your arms or legs • Kidney disorder.

Continued top of next column BBBA9667 Accord Healthcare Ltd, North Harrow, HA1 4HF, UK

Topiramate All strengths Film-coated Tablets PIL - UK