Sodium Valproate Wockhardt 200mg Gastro-Resistant Tablets
PACKAGE LEAFLET INFORMATION FOR THE USER
Orlept® 200mg and 500mg Gastro-Resistant Tablets
sodium valproate
▼ This medicine is subject to additional monitoring.
This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
WARNING
Valproate can cause birth defects and problems with early development of the child if it is taken during pregnancy. If you are a female of childbearing age you should use an effective method of contraception throughout your treatment.
Your doctor will discuss this with you but you should also follow the advice in section 2 of this leaflet. Tell your doctor at once if you become pregnant or think you might be pregnant._
Read all of this leaflet carefully before you start using 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, please ask your doctor or pharmacist.
- This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms 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.
The name of your medicine is Orlept® 200mg and 500mg Gastro-Resistant Tablets. In the rest of this leaflet it is called Orlept® Tablets.
What is in this leaflet
1. What Orlept® Tablets are and what they are used for
2. What you need to know before you take Orlept® Tablets
3. How to take Orlept® Tablets
4. Possible side effects
5. How to store Orlept® Tablets
6. Contents of the pack and other information
1. What Orlept® Tablets are and what they are used for What Orlept® Tablets are
The name of your medicine is Orlept® 200mg and 500mg Gastro-Resistant Tablets. In the rest of this leaflet it is called Orlept® Tablets.
What Orlept® Tablets contain
Orlept® Tablets contain sodium valproate. This belongs to a group of medicines called anticonvulsants or anti-epileptic agents. It works by helping to calm the brain down.
What Orlept® Tablets are used for
Orlept® Tablets are used to treat epilepsy (fits) in adults and children.
2. What you need to know before you take Orlept® Tablets Do not take Orlept® Tablets and tell your doctor if:
• you are allergic (hypersensitive) to sodium valproate or any of the other ingredients of Orlept®
Tablets (see Section 6: Further Information)
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
• you have liver problems or you or your family have a history of liver problems
• you have a rare illness called porphyria.
• you have a genetic problem caused by a mitochondrial disorder (e.g. Alpers-Huttenlocher syndrome)
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Orlept® Tablets.
Warnings and precautions
A small number of people being treated with anti-epileptics such as sodium valproate have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
Talk to your doctor or pharmacist before taking this medicine if:
• you have diabetes. This medicine may affect the results of urine tests
• you have kidney problems. Your doctor may give you a lower dose
• you have fits (epilepsy), brain disease or a metabolic condition affecting your brain
• you have a ‘urea cycle disorder’ where too much ammonia builds up in the body
• you have an illness called ‘systemic lupus erythematosus (SLE)’ - a disease of the immune system which affects skin, bones, joints and internal organs
• you know that there is a genetic problem caused by a mitochondrial disorder in your family.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Orlept® Tablets.
Weight gain
Taking Orlept® Tablets may make you put on weight. Talk to your doctor about how this will affect you.
Blood tests
Your doctor may wish to do blood tests before you start taking Orlept® Tablets and during your treatment.
Other medicines and Orlept® Tablets
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Orlept® Tablets can affect the way some other medicines work. Also some medicines can affect the way Orlept® Tablets work.
The following medicines can increase the chance of you getting side effects, when taken with Orlept® Tablets:
• Some medicines used for pain and inflammation (salicylates) such as aspirin
• Some other medicines used to treat fits (epilepsy) - see Section 3: “Patients taking other medicines for ‘fits.’” This includes medicines such as phenobarbital, primidone, phenytoin, carbamazepine, topiramate, lamotrigine and felbamate
Orlept® Tablets may increase the effect of the following medicines:
• Medicines used for thinning the blood (such as warfarin)
• Zidovudine used to treat HIV infection
• Temozolomide used to treat cancer
• Medicines for depression
• Monoamine oxidase inhibitors (MAOI) such as moclobemide, selegiline, linezolid
• Medicines used to calm emotional and mental conditions such as diazepam and olanzapine.
The following medicines can affect the way Orlept® Tablets work:
• Some medicines used for the prevention and treatment of malaria such as mefloquine and chloroquine
• Cimetidine used for stomach ulcers
• Carbapenem agents (antibiotics used to treat bacterial infections) such as imipenem, meropenem, rifampicin and erythromycin. The combination of Orlept® Tablets and carbapenems should be avoided because it may decrease the effect of your medicine.
• Colestyramine used to lower blood fat (cholesterol) levels.
Taking Orlept® Tablets with food and drink
Alcohol intake is not recommended during treatment.
Pregnancy and breast feeding and fertility IMPORTANT ADVICE FOR WOMEN
• Valproate can be harmful to unborn children when taken by a woman during pregnancy.
• Valproate carries a risk if taken during pregnancy. The higher the dose, the higher the risks but all doses carry a risk.
• It can cause serious birth defects and can affect the way in which the child develops as it grows. Birth defects which have been reported include spina bifida (where the bones of the spine are not properly developed); facial and skull malformations; heart, kidney, urinary tract and sexual organ malformations; limb defects.
• If you take valproate during pregnancy you have a higher risk than other women of having a child with birth defects that require medical treatment. Because valproate has been used for many years we know that in women who take valproate around 10 babies in every 100 will have birth defects. This compares to 2-3 babies in every 100 born to women who don’t have epilepsy.
• It is estimated that up to 30-40% of preschool children whose mothers took valproate during pregnancy may have problems with early childhood development. Children affected can be slow to walk and talk , intellectually less able than other children, and have difficulty with language and memory.
• Autistic spectrum disorders are more often diagnosed in children exposed to valproate and there is some evidence children may be more likely to develop symptoms of Attention Deficit Hyperactivity Disorder (ADHD).
• If you are a woman capable of becoming pregnant your doctor should only prescribe valproate for you if nothing else works for you.
• Before prescribing this medicine to you, your doctor will have explained what might happen to your baby if you become pregnant whilst taking valproate. If you decide later you want to have a child you should not stop taking your medicine until you have discussed this with your doctor and agreed a plan for switching you onto another product if this is possible.
• Ask your doctor about taking folic acid when trying for a baby. Folic acid can lower the general risk of spina bifida and early miscarriage that exists with all pregnancies. However, it is unlikely that it will reduce the risk of birth defects associated with valproate use.
FIRST PRESCRIPTION
If this is the first time you have been prescribed valproate your doctor will have explained the risks to an unborn child if you become pregnant. Once you are of childbearing age, you will need to make sure you use an effective method of contraception throughout your treatment. Talk to your doctor or family planning clinic if you need advice on contraception.
Key messages:
• Make sure you are using an effective method of contraception.
• Tell your doctor at once if you are pregnant or think you might be pregnant.
CONTINUING TREATMENT AND NOT TRYING FOR A BABY
If you are continuing treatment with valproate but you don’t plan to have a baby make sure you are using an effective method of contraception. Talk to your doctor or family planning clinic if you need advice on contraception.
Key messages:
• Make sure you are using an effective method of contraception
• Tell your doctor at once if you are pregnant or think you might be pregnant.
CONTINUING TREATMENT AND CONSIDERING TRYING FOR A BABY
If you are continuing treatment with valproate and you are now thinking of trying for a baby you must not stop taking either your valproate or your contraceptive medicine until you have discussed this with your prescriber. You should talk to your doctor well before you become pregnant so that you can put
several actions in place so that your pregnancy goes as smoothly as possible and any risks to you and your unborn child are reduced as much as possible.
Your doctor may decide to change the dose of valproate or switch you to another medicine before you start trying for a baby.
If you do become pregnant you will be monitored very closely both for the management of your underlying condition and to check how your unborn child is developing.
Ask your doctor about taking folic acid when trying for a baby. Folic acid can lower the general risk of spina bifida and early miscarriage that exists with all pregnancies. However, it is unlikely that it will reduce the risk of birth defects associated with valproate use.
Key messages:
• Do not stop using your contraception before you have talked to your doctor and worked together on a plan to ensure your epilepsy is controlled and the risks to your baby are reduced.
• Tell your doctor at once when you know or think you might be pregnant.
UNPLANNED PREGNANCY WHILST CONTINUING TREATMENT
Babies born to mothers who have been on valproate are at serious risk of birth defects and problems with development which can be seriously debilitating. If you are taking valproate and you think you are pregnant or might be pregnant contact your doctor at once. Do not stop taking your medicine until your doctor tells you to.
Ask your doctor about taking folic acid. Folic acid can lower the general risk of spina bifida and early miscarriage that exists with all pregnancies.
However, it is unlikely that it will reduce the risk of birth defects associated with valproate use.
Key messages:
• Tell your doctor at once if you know you are pregnant or think you might be pregnant.
• Do not stop taking valproate unless your doctor tells you to.
Make sure you read the patient booklet and sign the Acknowledgement of Risk form which should be given to you and discussed with you by your doctor or pharmacist.
Breast-feeding
Very little Orlept® Tablets Liquid gets into the breast milk. However, talk to your doctor about whether you should breast-feed your baby. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
You may feel sleepy when taking Orlept® Tablets. If this happens to you, do not drive or use any tools or machines. Taking other medicines used to treat fits or calm emotional and mental health problems may increase sleepiness.
Important information about some of the ingredients in this medicine Sodium
Orlept® 200mg Tablets contain 1.20 mmol and Orlept® 500mg Tablets contain 3.01 mmol of sodium per dose. This needs to be taken into consideration by patients on a controlled sodium diet.
3. How to take Orlept® Tablets
Always take Orlept® Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Orlept® Tablets treatment must be started and supervised by a doctor specialised in the treatment of epilepsy.
Taking this medicine
• Your doctor will decide how much Orlept® Tablets to give you or your child depending on your or your child’s body weight
• Take this medicine by mouth
• Take Orlept® Tablets with or after food. This will help to stop the feelings of sickness that may happen after taking Orlept® Tablets
• Do not crush or chew the tablets
• If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself but ask your doctor
How to take this medicine
• The dose is normally split and given half in the morning and half in the evening.
How much to take
Adults (including the elderly)
• The starting dose is 600mg a day daily. Your doctor should gradually increase this dose by 200mg every 3 days depending on your condition.
• The usual dose is between 1000mg and 2000mg (20-30mg per kilogram of body weight) each day
• This may be increased to 2,500mg each day depending on your illness.
Children over 20 kilograms
• The starting dose should be 400mg daily. Your doctor should increase this dose depending on your child’s illness
• The usual dose is then between 20mg and 30mg for each kilogram of body weight each day
• This may be further increased to 35mg for each kilogram of body weight each day depending on your child’s illness
Children under 20 kilograms
• The usual dose is 20mg for each kilogram of body weight each day
• Depending on the child’s condition your child’s doctor may decide to increase this dose Patients with kidney problems
• Your doctor may decide to adjust your or your child’s dose Patients taking other medicines for ‘fits’ (epilepsy)
• You or your child may be taking other medicines for epilepsy at the same time as Orlept® Tablets. If so, your doctor should gradually initiate treatment depending on you or your child’s condition
• Your doctor may increase the dose of Orlept® Tablets by 5 to 10mg for each kilogram of body weight each day depending on which other medicines you are taking
If you take more Orlept® Tablets than you should
If you take too many tablets contact your doctor, pharmacist or nearest hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken.
The following effects may happen:-g feeling sick or being sick, pupils of the eye becoming smaller, dizziness, sleepiness, loss of consciousness, weak muscles, poor reflexes, breathing problems, headaches, fits (seizures), confusion, memory loss and unusual or inappropriate behaviour.
If you forget to take Orlept® Tablets
If you forget to take a dose, take it as soon as you remember.-However, if it nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
Stopping Orlept® Tablets
Keep taking Sodium Valproate Tablets until your doctor tells you to stop. If your doctor advises you to stop taking Sodium Valproate Tablets, (perhaps in order to start another medicine for your epilepsy) this will be done gradually to maintain control of your fits. Do not stop taking Sodium Valproate Tablets without talking to your doctor first and never suddenly stop taking your Sodium Valproate Tablets if you are pregnant since this may result in fits which may harm you or your unborn child.
Tests
Make sure you or your child keep your regular appointments for a check up. They are very important as your or your child’s dose may need to be changed. Orlept® Tablets can change the levels of liver
enzymes shown up in blood tests. This can mean that your or your child’s liver is not working properly.
If you or your child go into hospital or visit another doctor or a dentist, tell them you are taking Orlept®
Tablets.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines Orlept® Tablets can cause side effects, although not everybody gets them.
Tell your doctor straight away if you notice any of the following serious side effects - you may
need urgent medical treatment:
• You have an allergic reaction. The signs may include: a rash, joint pain, fever (systemic lupus erythematosus), swallowing or breathing problems, swelling of your lips, face, throat or tongue. Hands, feet or genitals may also be affected. More severe allergic reactions can lead to lymph node enlargement and possible impairment of other organs.
• Liver problems and problems of the pancreas may show as a sudden illness which may happen in the first six months of treatment. This happens in a very small number of people taking Orlept® Tablets. It includes feeling and being sick many times, being very tired, sleepy and weak, stomach pain including very bad upper stomach pain, jaundice (yellowing of the skin or whites of the eyes), loss of appetite, swelling (especially of the legs and feet but may include other parts of the body), worsening of your fits or a general feeling of being unwell.
Your doctor may tell you to stop taking Orlept® Tablets immediately if you have these symptoms.
• You have a skin rash or skin lesions with a pink/red ring and a pale centre which may be itchy, scaly or filled with fluid. The rash may appear especially on the palms or soles of your feet. These could be signs of a serious allergy to the medicine called ‘erythema multiforme.’
• Blistering or bleeding of the skin around the lips, eyes, mouth, nose and genitals. Also flu-like symptoms and fever. This may be something called ‘Stevens-Johnson syndrome.’
• Severe blistering rash where layers of the skin may peel off to leave large areas of raw exposed skin over the body. Also a feeling of being generally unwell, fever, chills and aching muscles. This may be something called ‘Toxic epidermal necrolysis.’
• Bruising more easily and getting more infections than usual. This could be a blood problem called ‘thrombocytopenia’. It can also be due to a fall in the number of white blood cells, bone marrow depression or another condition that affects red blood cells, white blood cells and platelets (pancytopenia) or how the blood clots.
• Blood clotting problems (bleeding for longer than normal), bruising or bleeding for no reason.
• Changes in mood, loss of memory, lack of concentration and deep loss of consciousness (coma).
• Underactive thyroid gland, which may cause tiredness or weight gain (hypothyroidism).
• Breathing difficulty and pain due to inflammation of the lungs (pleural effusion).
Tell your doctor as soon as possible if you have any of the following side effects:
• Changes in behaviour including being very alert, and sometimes also aggressive, hyper-active and unusual or inappropriate behaviour. This is more likely if other medicine to treat fits such as Phenobarbital and topiramate are taken at the same time or if the Orlept® Tablets starting dose is high or has been suddenly increased.
• Changes in the amount of ammonia in the blood. Symptoms of this condition are being sick, problems with balance and co-ordination, feeling lethargic or less alert.
• Feeling shaky (tremor), sleepy or unsteady when walking or jerky muscle movements
• Feeling tired or confused with loss of consciousness sometimes accompanied by hallucinations or fits.
• Blisters with the skin flaking away.
• Rapid, uncontrollable movement of the eyes.
Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than
a few days, or if you notice any side effects not listed in this leaflet:
• Feeling sick, stomach ache or diarrhoea, especially when starting treatment. This may be helped by taking the tablets with food
• Fainting
• Hearing loss
• Skin problems such as rashes. These happen rarely, but more often in people also taking lamotrigine
• Acne
• Hair loss which is usually temporary. When it grows back it may be more curly than before
• Hair, including body or facial hair grows more than normal in women
• Skin rash caused by narrow or blocked blood vessels (vasculitis)
• Changes in women’s periods and increased hair growth in women
• Breast enlargement in men
• Swelling of the feet and legs (oedema)
• Weight gain, leading to obesity in rare cases - as your appetite may be increased
• Kidney problems, bedwetting or increased need to pass urine
• Headache
• Aggression, agitation, disturbance in attention, abnormal behaviour, restlessness/hyperactivity, and learning disorder
• Tingling or numbness in the hands and feet
• Nail and nail bed disorders are common
Bone disorders
There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures. Check with your doctor or pharmacist if you are on long-term antiepileptic medication, have a history of osteoporosis, or take steroids.
Blood tests
Orlept® Tablets can change levels of liver enzymes, salts or sugars shown up on blood and urine tests. Male fertility
Taking Orlept® Tablets can be a contributing factor in male infertility.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Orlept® Tablets
Keep this medicine out of the sight and reach of children.
Do not take this medicine if the expiry date on the carton has passed. The expiry date refers to the last day of that month.
Orlept® Tablets should not be taken if they show signs of deterioration such as discoloration.
Store below 25°C.
Store in the original container or package in order to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information What Orlept® Tablets contain
• Each tablet contains 200mg or 500mg of the active substance sodium valproate.
• The other ingredients are microcrystalline cellulose anhydrous, methylated colloidal anhydrous silica, enzymatically hydrolysed gelatine, calcium behenate, talc, triacetin, titanium dioxide (E171), macrogol and methylacrylic acid copolymer.
What Orlept® Tablets look like and contents of the pack
Orlept® 200mg Gastro-Resistant Tablets are white to faintly yellowish, round, bevel edged gastro-resistant tablets.
Orlept® 500mg Gastro-Resistant Tablets are white, oval gastro-resistant tablets.
Tablets are supplied in polypropylene or polyethylene containers or glass bottles of 100 tablets and blister packs of 10, 50, 60 or 100 tablets.
Marketing Authorisation Holder: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK. Manufacturer: Desitin Arzneimittel, Hamburg, Germany.
This leaflet was last revised in 12/2015 Other sources of information
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only)
Please be ready to give the following information: _
|
Product Name |
Reference number |
|
Orlept® 200mg Gastro-Resistant Tablets |
29831/0189 |
|
Orlept® 500mg Gastro-Resistant Tablets |
29831/0190 |
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