Skip to Content

ZONISAMIDE RECLINMED 25 MG HARD CAPSULES

Active substance(s): ZONISAMIDE / ZONISAMIDE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package leaflet: Information for the user
Zonisamide Reclinmed 25 mg hard capsules
Zonisamide Reclinmed 50 mg hard capsules
Zonisamide Reclinmed 100 mg hard capsules
zonisamide
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.
2.
3.
4.
5.
6.

What Zonisamide Reclinmed is and what it is used for
What you need to know before you take Zonisamide Reclinmed
How to take Zonisamide Reclinmed
Possible side effects
How to store Zonisamide Reclinmed
Contents of the pack and other information

1.

What Zonisamide Reclinmed is and what it is used for

Zonisamide Reclinmed contains the active substance zonisamide, and is used as an antiepileptic medicine.
Zonisamide Reclinmed is used to treat seizures that affect one part of the brain (partial seizure), which may or
may not be followed by a seizure affecting all of the brain (secondary generalisation).
Zonisamide Reclinmed may be used:
• On its own to treat seizures in adults.
• With other antiepileptic medicines to treat seizures in adults, adolescents, and children aged 6 years and
above.

2.

What you need to know before you take Zonisamide Reclinmed

Do not take Zonisamide Reclinmed:
If you:
• are allergic to zonisamide or any of the ingredients in Zonisamide Reclinmed (listed in section 6),
• are allergic to other sulphonamide medicines. Examples include: sulphonamide antibiotics, thiazide
diuretics, and sulfonylurea antidiabetes medicines.
Warnings and precautions:
Zonisamide Reclinmed belongs to a group of medicines (sulphonamides) which can cause severe allergic
reactions, severe skin rashes, and blood disorders, which very rarely can be fatal (see section 4 Possible side
effects).

Serious rashes occur in association with Zonisamide Reclinmed therapy, including cases of StevensJohnson syndrome.

Talk to your doctor or pharmacist before taking Zonisamide Reclinmed if you:
• are younger than 12 years old, as you may be at greater risk of decreased sweating, heat stroke,
pneumonia and liver problems. If you are younger than 6 years old, Zonisamide Reclinmed is not
recommended for you.
• are elderly, as your dose of Zonisamide Reclinmed may need adjusting, and you may be more likely to
develop an allergic reaction, severe skin rash, swelling of the feet and legs, and itchiness when taking
Zonisamide Reclinmed (see section 4 Possible Side Effects).
• suffer from liver problems, as your dose of Zonisamide Reclinmed may need adjusting.
• have eye problems such as glaucoma.
• suffer from kidney problems as your dose of Zonisamide Reclinmed may need adjusting.
• have previously suffered from kidney stones, as you may be at increased risk of developing more kidney
stones. Reduce the risk of kidney stones by drinking sufficient water.
• live in a place or are on holiday in a place where the weather is warm. Zonisamide Reclinmed can make
you perspire less, which can cause your body temperature to increase. Reduce the risk of overheating
by drinking sufficient water and keeping cool.
• are underweight, or have lost a lot of weight as Zonisamide Reclinmed can cause you to lose more
weight. Tell your doctor as this may need to be monitored.
If any of these applies to you, tell your doctor before you take Zonisamide Reclinmed.
Children and adolescents
Talk to your doctor about the following risks:
Preventing overheating and dehydration in children
Zonisamide Reclinmed can cause your child to sweat less and overheat and if your child is not treated this can
lead
to brain damage and death. Children are most at risk especially in hot weather.
When your child is taking Zonisamide Reclinmed: Keep your child cool especially in hot weather
• Your child must avoid heavy exercise especially when the weather is hot
• Give your child plenty of cold water to drink
• Your child must not take these medicines:
• Carbonic anhydrase inhibitors (like topiramate and acetazolamide), and anticholinergic agents (like
clomipramine, hydroxyzine, diphenhydramine, haloperidol, imipramine and oxybutynin).
If your child’s skin feels very hot with little or no sweating, becomes confused, has muscle cramps, or your
child’s heartbeat or breathing becomes rapid:

Take your child to a cool, shaded place

Sponge your child’s skin with cool (not cold) water

Give your child cold water to drink

Seek urgent medical assistance.





Body weight: You should monitor your child’s weight every month and see your doctor as soon
as possible if your child is not gaining enough weight. Zonisamide Reclinmed is not recommended for
children who are underweight or have a small appetite, and should be used with caution in those below 20
kg.
Increased acid level in the blood and kidney stones: Reduce these risks by ensuring that your child drinks
enough water and is not taking any other medicine which could cause kidney stones (see Other
medicines). Your doctor will monitor your child’s blood bicarbonate levels and kidneys
(see also section 4).

Do not give this medicine to children below the age of 6 years because it is not known for this age group

whether the potential benefits are greater than the risks.
Other medicines and Zonisamide Reclinmed
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.




Zonisamide Reclinmed should be used carefully in adults when taken with medicines that can cause
kidney stones, like topiramate or acetazolamide. In children, this combination is not recommended
Zonisamide Reclinmed could possibly increase your blood levels of medicines like digoxin and quinidine,
and so a reduction in their dose may be required.
Other medicines like phenytoin, carbamazepine, phenobarbitone and rifampicin can decrease your blood
levels of Zonisamide Reclinmed, which may require an adjustment of your dose of Zonisamide
Reclinmed.

Zonisamide Reclinmed with food and drink
Zonisamide Reclinmed can be taken with or without food.
Pregnancy, breastfeeding and fertility
If you are a woman of childbearing age you must use adequate contraception while taking and for one month
after stopping Zonisamide Reclinmed.
Tell your doctor immediately if you might be, or are pregnant, or are planning to get pregnant.
You must only take Zonisamide Reclinmed during your pregnancy if your doctor tells you to. Research has
shown an increased risk of birth defects in children of women taking anti-epileptic medicines.
Do not breastfeed whilst taking, or for one month after stopping Zonisamide Reclinmed.
There are no clinical data available on the effects of Zonisamide Reclinmed on human fertility. Studies in
animals have shown changes in fertility parameters.
Driving and using machines
Zonisamide Reclinmed may affect your concentration, ability to react/respond, and may make you feel sleepy,
particularly at the beginning of your treatment or after your dose is increased. Be especially careful while
driving or operating machinery, if Zonisamide Reclinmed affects you in this way.

3.

How to take Zonisamide Reclinmed

Always take Zonisamide Reclinmed exactly as your doctor has told you. You should check with your doctor
or pharmacist if you are not sure.
The usual adult dose
When you take Zonisamide Reclinmed on its own:

The starting dose is 100 mg taken once a day.

This may be increased by up to 100 mg at intervals of two weeks.

The usual dose is 300 mg once a day.
When you take Zonisamide Reclinmed with other antiepileptic medicines:
• The starting dose is 50 mg daily taken in two equal doses of 25 mg.
• This may be increased by up to 100 mg at intervals of one to two weeks.
• The usual daily dose is between 300 mg and 500 mg.
• Some people respond to lower doses. The dose may be increased more slowly if you experience side
effects, are elderly or if you suffer from kidney or liver problems.
Use in children (aged 6 to 11 years) and adolescents (aged 12 to 17 years) weighing at least 20 kg:





The starting dose is 1 mg per kg of body weight taken once a day.
This may be increased by 1 mg per kg of body weight at intervals of one to two weeks.
The usual daily dose is 6 to 8 mg per kg for a child with a body weight of up to 55 kg or 300 to 500 mg
for a child with a body weight more than 55 kg (which ever dose is lower) taken once a day.

Example: A child who weighs 25 kg should take 25 mg once a day for the first week, and then increase the
daily dose by 25 mg at the start of each week until a daily dose between 150 to 200 mg is reached.
If you feel that the effect of Zonisamide Reclinmed is too strong or too weak, talk to your doctor or
pharmacist.
How and when to take the capsules
• Zonisamide Reclinmed capsules must be swallowed whole with water.
• Do not chew the capsules.
• Zonisamide Reclinmed can be taken once or twice daily, as instructed by your doctor.
• If you take Zonisamide Reclinmed twice a day, take half the daily dose in the morning and half in the
evening.
If you take more Zonisamide Reclinmed than you should
If you may have taken more Zonisamide Reclinmed than you should, tell a carer (relative or friend), your
doctor or pharmacist immediately, or contact your nearest hospital casualty department, taking your medicine
with you. You may become sleepy and could lose consciousness. You might also feel sick, have a sore
stomach, muscle twitches, eye movement, feel faint, have a slowed heartbeat, and reduced breathing and
kidney function. Do not try to drive.
If you forget to take Zonisamide Reclinmed

If you forget to take a dose, don’t worry: take the next dose when it is due.

Do not take double the dose to make up for the forgotten dose.
If you stop taking Zonisamide Reclinmed

Zonisamide Reclinmed is meant to be taken as a long-term medicine. Do not reduce your dose or stop
your medicine unless your doctor tells you to.

If your doctor advises you to stop taking Zonisamide Reclinmed your dose will be reduced gradually to
lower the risk of more seizures.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, Zonisamide Reclinmed can cause side effects, although not everybody gets them.
Zonisamide Reclinmed belongs to a group of medicines (sulphonamides) that can cause severe allergic
reactions, severe skin rashes, and blood disorders, which very rarely can be fatal.
Contact your doctor immediately if you:
• have difficulty breathing, a swollen face, lips or tongue, or a severe skin rash as these symptoms may
indicate that you are having a severe allergic reaction.
• have signs of overheating - high body temperature but little or no sweating, rapid heartbeat and breathing,
muscle cramps, and confusion.
• have thoughts of harming or killing yourself. A small number of people being treated with antiepileptics such as Zonisamide Reclinmed have had thoughts of harming or killing themselves.
• have pain in your muscles or a feeling of weakness, as this may be a sign of abnormal muscle breakdown
which can lead to kidney problems.
• get a sudden pain in your back or stomach, have pain on urinating (passing water) or notice blood in your



urine, as this may be a sign of kidney stones.
develop visual problems such as eye pain or blurred vision while taking Zonisamide Reclinmed.

Contact your doctor as soon as possible if you:
• have an unexplained skin rash, as this could develop into a more severe skin rash or skin peeling.
• feel unusually tired or feverish, have a sore throat, swollen glands, or find that you bruise more easily, as
this may mean you have a blood disorder.
• have signs of increased acid level in the blood- headaches, drowsiness, shortness of breath and loss of
appetite. Your doctor may need to monitor or treat this.
Your doctor may decide that you should stop using Zonisamide Reclinmed.
The most common side effects of Zonisamide Reclinmed are mild. They occur during the first month of
treatment and usually decrease with continued treatment. In children ages 6 – 17 years old, side effects were
consistent with those described below with the following exceptions: pneumonia, dehydration, sweating
decreased (common) and abnormal liver enzymes (uncommon).
Very common side effects (may affect more than 1 in 10 people)
• agitation, irritability, confusion, depression
• poor muscle coordination, dizziness, poor memory, sleepiness, double vision
• loss of appetite, decreased blood levels of bicarbonate (a substance that prevents your blood from
becoming acidic)
Common side effects (may affect up to 1 in 10 people)
• difficulty sleeping, strange or unusual thoughts, feeling anxious or emotional.
• slowed thoughts, loss of concentration, speech abnormalities, abnormal skin sensation (pins and needles),
tremor, involuntary movement of the eyes.
• kidney stones.
• skin rashes, itching, allergic reactions, fever, tiredness, flu-like symptoms, hair loss.
• ecchymosis (a small bruise caused by blood leaking from broken blood vessels in the skin).
• loss of weight, nausea, indigestion, stomach pains, diarrhoea (loose stools), constipation.
• swelling of the feet and legs.
Uncommon side effects (may affect up to 1 in 100 people)

anger, aggression, thoughts of suicide, suicide attempt.

vomiting.

gall bladder inflammation, gallstones.

urinary stones.

lung infection / inflammation, urinary tract infections.

low blood potassium levels, convulsions/seizures.
Very rare side effects ( may affect up to 1 in 10,000 people)
• hallucinations, memory loss, coma, neuroleptic malignant syndrome (inability to move, sweating, fever,
incontinence), status epilepticus (prolonged or repeated seizures).
• breathing disorders, shortness of breath, inflammation of the lungs.
• inflammations of the pancreas (severe pain in the stomach or back)
• liver problems, kidney failure, increased blood levels of creatinine (a waste product that your kidneys
should normally remove). .
• severe rashes or skin peeling (at the same time you may feel unwell or develop a fever).
• abnormal muscle breakdown (you may feel pain or weakness in your muscles) which can lead to kidney
problems.
• swollen glands, blood disorders (reduction in the number of blood cells, which can make infection more
likely and can make you look pale, feel tired and feverish, and bruise more easily).
• decreased sweating, overheating.
• glaucoma, which is a blockage of fluid in the eye causing increased pressure in the eye. Eye pain, blurred

vision or decreased vision may occur and can be signs of glaucoma.

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 listed in Appendix V
By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Zonisamide Reclinmed

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 blister and the carton after EXP. The
expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.
Do not use if you notice any damage to the capsules, blister or carton or any visible signs of deterioration in
the medicine. Return the pack to your pharmacist.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer require. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Zonisamide Reclinmed contains
The active substance in Zonisamide Reclinmed is zonisamide.
Zonisamide Reclinmed 25 mg hard capsules contain 25 mg of zonisamide.
Zonisamide Reclinmed 50 mg hard capsules contain 50 mg zonisamide.
Zonisamide Reclinmed 100 mg hard capsules contain 100 mg zonisamide.

The other ingredients that are present in the capsule contents are: microcrystalline cellulose,
hydrogenated vegetable oil and sodium lauryl sulpfate. The printing ink contains schellac (E904), potassium
hydroxide and iron oxide black (E172).


The capsule shell contains: gelatin, titanium dioxide (E171). Additionally the 50mg capsule shell
contains iron oxide black (E172) and the 100mg capsule shell contains quinoline yellow (E104) and
erythrosine (E127)..

What Zonisamide Reclinmed looks like and contents of the pack
- Zonisamide Reclinmed 25 mg hard capsules have an opaque white cap and body, imprinted with a 'G' and
'742' , approximately 14.40±0.5 mm in length.
- Zonisamide Reclinmed 50 mg hard capsules have an opaque grey cap and opaque white body, imprinted
with a 'G' and '743', approximately 15.80±0.5 mm in length.
- Zonisamide Reclinmed 100 mg hard capsules have an opaque red cap and opaque white body, imprinted
with a 'G' and '744', approximately 19.20±0.5 mm in length..
Zonisamide Reclinmed capsules are packaged in blisters supplied in boxes containing: 14, 28, 56, 84, 98 and
196 hard capsules.
Not all pack sizes may be available.

Marketing Authorisation Holder
Reclinmed s.r.o.,
Prubezna 41/387,
Prague 10, CZ 100 87,
Czech Republic.
Manufacturer
Glenmark Pharmaceuticals Europe Limited,
Building 2, Croxley Green Business Park,
Marlins Meadow, Watford, WD18 8YA, UK.

This leaflet was last revised in 06 /2017

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide