TOPIRAMATE RENATA 25 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• - Keep this leaflet. You may need to read it again.

• - If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

• - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Topiramate Renata is and what it is used for

• 2. What you need to know before you take Topiramate Renata

• 3. How to take Topiramate Renata

• 4. Possible side effects

• 5. How to store Topiramate Renata

• 6. Contents of the pack and other information

1. what topiramate renata is and what it is used for

Topiramate belongs to a group of medicines called “anti-epileptic medicines”. It is used:

• alone to treat seizures in adults and children over age 6
• with other medicines to treat seizures in adults and children aged 2 years and above
• to prevent migraine headaches in adults.

2. what you need to know before you take topiramate renata- if you are allergic (hypersensitive) to topiramate or 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 effective contraception (see “Pregnancy, breast-feeding and fertility” section for further information). You should talk to your doctor about the best kind of contraception to use while you are taking Topiramate Renata.

If you are not sure if the above applies to you, talk to your doctor or pharmacist before taking Topiramate Renata.

Warnings and precautions

Talk to your doctor or pharmacist before taking Topiramate Renata if you:

• - have kidney problems, especially kidney stones, or are having kidney dialysis

• - have a history of blood and body fluid abnormality (metabolic acidosis)

• - have liver problems

• - have eye problems, especially glaucoma

• - have a growth problem

• - are on a high fat diet (ketogenic diet)

• - are taking Topiramate Renata to treat epilepsy and you are pregnant or a woman of childbearing potential (see “pregnancy, breastfeeding and fertility” – section for further information)

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Topiramate Renata.

It is important that you do not stop taking your medicine without first consulting your doctor. You should also talk to your doctor before taking any medicine containing topiramate that is given to you as an alternative to this medicine.

You may lose weight if you use topiramate so your weight should be checked regularly when using this medicine. If you are losing too much weight or a child using this medicine is not gaining enough weight, you should consult your doctor.

A small number of people being treated with anti-epileptic medicines such as topiramate have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Topiramate Renata may in rare cases cause high levels of ammonia in the blood (seen in blood tests) which can lead to a change in brain function, especially if you are also taking a medicine called valproic acid or sodium valproate. Since this may be a severe condition, tell your doctor immediately if the following symptoms occur (see also section 4 ‘Possible side effects’):

• - difficulty thinking, remembering information, or solving problems

• - being less alert or aware

• - feeling very sleepy with low energy

At higher doses of Topiramate Renata, the risk of developing these symptoms may increase.

Other medicines and Topiramate Renata

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, Topiramate Renata and certain other medicines can affect each other. Sometimes the dose of some of your other medicines or this medicine will have to be adjusted.

Especially, tell your doctor or pharmacist if you are taking:

• other medicines that impair or decrease your thinking, concentration, or muscle coordination (e.g. central nervous system depressant medicines such as muscle relaxants and sedatives).
• birth control pills. This medicine may make your birth control pills less effective. You should talk to your doctor about the best kind of contraception to use while you are taking Topiramate Renata.

Tell your doctor if your menstrual bleeding changes while you are taking birth control pills and topiramate.

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

Other medicines you should discuss with your doctor or pharmacist include other anti-epileptic medicines, risperidone, lithium, hydrochlorothi­azide, metformin, pioglitazone, glibenclamide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarazine, St. John’s Wort (Hypericum perforatum ; a herbal preparation used to treat depression), warfarin used to thin the blood.

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

Topiramate Renata with food and drink

You can take topiramate with or without food. Drink plenty of fluids during the day to prevent kidney stones while taking Topiramate Renata. You should avoid drinking alcohol when taking Topiramate Renata.

Pregnancy, breast-feeding and fertility

Migraine prevention:

Topiramate Renata can harm an unborn baby. You must not use Topiramate Renata if you are pregnant. You must not use Topiramate Renata for migraine prevention if you are a woman of childbearing potential unless you are using effective contraception. Talk to your doctor about the best kind of contraception and whether Topiramate Renata is suitable for you. Before the start of treatment with Topiramate Renata a pregnancy test should be performed.

Treatment of epilepsy:

If you are a woman of childbearing potential you should talk to your doctor about other possible treatments instead of Topiramate Renata. If the decision is made to use Topiramate Renata, you should use effective contraception. Talk to your doctor about the best kind of contraception to use while you are taking Topiramate Renata. Before the start of treatment with Topiramate Renata a pregnancy test should be performed.

Talk to your doctor if you wish to become pregnant.

As with other anti-epileptic medicines, there is a risk of harm to the unborn child if topiramate if used during pregnancy. Make sure you are very clear about the risks and the benefits of using topiramate for epilepsy during pregnancy.

• – If you take Topiramate Renata during pregnancy, your baby has a higher risk of birth defects, particularly, cleft lip (split in the top lip) and cleft palate (split in the roof of the mouth). Newborn boys may also have a malformation of the penis (hypospadia). These defects can develop early in pregnancy, even before you know you are pregnant.

• – If you take Topiramate Renata during pregnancy, your baby may be smaller than expected at birth. Talk to your doctor if you have questions about this risk during pregnancy.

• – There may be other medicines to treat your condition that have a lower risk of birth defects.

• – Tell your doctor straight away if you become pregnant while taking Topiramate Renata. You and your doctor should decide if you will continue to take Topiramate Renata while you are pregnant.

Breast-feeding

The active substance in Topiramate Renata (topiramate) passes into breast milk. Effects have been seen in breastfed babies of treated mothers including diarrhoea, feeling sleepy, feeling irritable, and poor weight gain. Therefore, your doctor will discuss with you whether you abstain from breastfeeding or whether to abstain from treatment with Topiramate Renata. Your doctor will take into account the importance of the medicine to the mother and the risk for the baby.

Mothers who breast-feed while taking topiramate must tell the doctor as soon as possible if the baby experiences anything unusual.

Driving and using machines

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

Topiramate Renata contains lactose

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

Warning! Each bottle contains a desiccant capsule. This is a small canister on which ’Do not eat’ is written. Do not eat this.

3. how to take topiramate renata

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• Take topiramate exactly as prescribed. Your doctor will usually start you on a low dose of topiramate and slowly increase your dose until the best dose is found for you.
• Topiramate Renata are to be swallowed whole. Avoid chewing the tablets as they may leave a bitter taste.
• Topiramate can be taken before, during, or after a meal. Drink plenty of fluids during the day to prevent kidney stones while taking topiramate.

If you take more Topiramate Renata than you should

• See a doctor right away. Take the medicine pack with you.
• You may feel sleepy, tired, or less alert; lack coordination; have difficulty speaking or concentrating; have double or blurred vision, feel dizzy due to low blood pressure, feel depressed or agitated, or have abdominal pain, or seizures (fits).

Overdose can happen if you are taking other medicines together with topiramate.

If you forget to take Topiramate Renata

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 Topiramate Renata

Do not stop taking this medicine unless told to do so by your doctor. Your symptoms may return. If doctor decides to stop this medication, your dose may be decreased gradually over few days.

If you have any further questions on the use of 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.

Tell your doctor, or seek medical attention immediately if you have the following side effects:

• Depression (new or worse)

Common (may affect up to 1 in 10 people)

• Seizures (fits)
• Anxiety, irritability, changes in mood, confusion, disorientation
• Problems with concentration, slowness of thinking, loss of memory, problems with memory (new onset, sudden change or increased severity)
• Kidney stones, frequent or painful urination

Uncommon (may affect up to 1 in 100 people)

• Increased acid level in the blood (may cause troubled breathing including shortness of breath, loss of appetite, nausea, vomiting, excessive tiredness, and fast or irregular heart beats)
• Decreased or loss of sweating (particularly in young children who are exposed to high temperatures)
• Having thoughts of serious self-harm, trying to cause serious self-harm
• Loss of part of the field of vision

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

• Glaucoma – blockage of fluid in eye causing increased pressure in the eye, pain, or decreased vision.
• Difficulty thinking, remembering information, or solving problems, being less alert or aware, feeling very sleepy with low energy – these symptoms may be a sign of a high level of ammonia in the blood (hyperammonemia), which can lead to a change in brain function (hyperammonemic encephalopathy).

Other side effects include the following, if they get serious, please tell your doctor or pharmacist:

Stuffy, runny nose or sore throat

• Tingling, pain and/or numbness of various body parts
• Sleepiness, tiredness
• Dizziness
• Nausea, diarrhoea
• weight loss

Common (may affect up to 1 in 10 people)

• Anaemia (low blood count)
• Allergic reaction (such as skin rash, redness, itching, facial swelling, hives)
• Loss of appetite, decreased appetite
• Aggression, agitation, anger, abnormal behaviour
• Difficulty falling or staying asleep
• Problems with speech or speech disorder, slurred speech
• Clumsiness, or lack of coordination, feeling of unsteadiness when walking
• Decreased ability to complete routine tasks
• Decreased, loss of, or no sense of taste
• Involuntary trembling or shaking; rapid, uncontrollable movements of the eyes
• Visual disturbance, such as double vision, blurred vision, decreased vision, difficulty focusing
• Sensation of spinning (vertigo), ringing in the ears, ear pain
• Shortness of breath
• Cough
• Nose bleeds
• Fever, not feeling well, 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 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 Renata may feel faint, dizzy, or may pass out when they stand up or sit up suddenly)
• Flushing, feeling warm
• Pancreatitis (inflammation of the pancreas)
• 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
• Stevens-Johnson syndrome, a potentially life-threatening condition that may present with sores in multiple mucosal sites (such as the mouth, nose, and eyes), a skin rash, and blistering
• Abnormal skin odour
• Discomfort in your arms or legs
• Kidney disorder

Not known (frequency cannot be estimated from the available data)

• Maculopathy is a disease of the macula, the small spot in the retina where vision is keenest. You should call your doctor if you notice a change or decrease in your vision.
• Toxic epidermal necrosis, a life-threatening condition related to, yet more severe than, Stevens-Johnson syndrome, characterized by widespread blistering and sloughing of the outer layers of the skin (see rare side effects).
• Inflammation of the eye (uveitis) with symptoms such as eye redness, pain, sensitivity to light, runny eyes, seeing small dots or getting blurred vision.

Children

The side effects in children are generally similar to those seen in adults, but the following side effects may be more common in children than adults:

• Problems with concentration
• Increased acid level in the blood
• Having thoughts of serious self-harm
• Tiredness
• Decreased or increased appetite
• Aggression, abnormal behaviour
• Difficulty falling or staying asleep
• Feeling of unsteadiness when walking
• Not feeling well
• Decrease in potassium level in the blood
• Showing and/or feeling no emotion
• Watery eyes
• Slow or irregular heartbeat

Other side effects that may occur in children are:

Common (may affect up to 1 in 10 people)

• Sensation of spinning (vertigo)
• Vomiting
• Fever

Uncommon (may affect up to 1 in 100 people)

• Increase in eosinophils (a type of white blood cell) in the blood
• Hyperactivity
• Feeling warm
• Learning disability

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 Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store topiramate renata

Keep this medicine out of sight and reach of children. Do not use this medicine after the expiry date, which is stated on the carton and bottle or blister after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C. Keep the container tightly closed in order to protect from moisture.

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

6. contents of the pack and other informationthe active substance is topiramate.

Each film-coated tablet contains 25 mg topiramate.

Each film-coated tablet contains 50 mg topiramate.

Each film-coated tablet contains 100 mg topiramate.

Each film-coated tablet contains 200 mg topiramate.

The other ingredients are lactose monohydrate (see section 2: Topiramate Renata contain lactose), cellulose microcrystalline, starch, pregelatinised (i.e. potato starch), croscarmellose sodium and magnesium stearate.

• - The 25 mg tablets are coated with hypromellose (E464), titanium dioxide (E171) and macrogol 6000.

• - The 50 mg and 100 mg tablets are coated with hypromellose (E464), titanium dioxide (E171), macrogol 6000, iron oxide yellow (E172).

• - The 200 mg tablets are coated with hypromellose (E464), titanium dioxide (E171), macrogol 6000, iron oxide red (E172).

What Topiramate Renata looks like and contents of the pack

Film-coated tablet.

Topiramate Renata is available in four strengths containing either 25 mg, 50 mg, 100 mg and 200 mg topiramate.

The 25 mg film-coated tablets are 6 mm, white coloured, round, biconvex with bevelled edges; embossed “TP” on one side and “25” on the other.

The 50 mg film-coated tablets are 7 mm, light yellow coloured, round, biconvex with bevelled edges; embossed “TP” on one side and “50” on the other.

The 100 mg film-coated tablets are 9 mm, dark yellow coloured, round, biconvex with bevelled edges; embossed “TP” on one side and “100” on the other.

The 200 mg film-coated tablets are 12.73 mm, red coloured, round, biconvex with bevelled edges embossed “TP” on one side and “200” on the other.

Topiramate film-coated tablets are available in aluminium/aluminium blisters in packs sizes of 10, 20, 28, 30, 50, 56, 60 and 100 film-coated tablets or in high density polyethylene (HDPE) bottles fitted with a white opaque polypropylene child resistant closure with wad having induction sealing liner supplied in cardboard cartons in pack sizes of 60 film-coated tablets. In each container there is a desiccant canister, which should not be swallowed.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Renata (UK) Limited

Greenway Business Center,

Harlow Business Park

Harlow

CM19 5QE

United Kingdom

Distributed by:

Lucis Pharma Ltd

14 Aston Magna,

Moreton in Marsh,

Gloucestershire, GL56 9QQ,

United Kingdom

Manufacturer

Strandhaven Limited

641, High Road,

Ilford,

IG3 8RA

United Kingdom

This leaflet was last revised in Dec 2020.

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