Syonell 250 mg gastro-resistant tablets – patient leaflet, side effects, dosage

1. What Syonell is and what it is used for What Syonell is

The name of your medicine is Syonell 250 mg Gastro-Resistant tablets or 500 mg Gastro-Resistant tablets (called Syonell in this leaflet).

What Syonell contains

Syonell contains a medicine called valproate semisodium. This belongs to a group of medicines called mood stabilisers. It works by stabilising the levels of chemicals in your brain that affect your mood.

What Syonell is used for

Syonell can be used to manage or control mania (feeling highly excited, enthusiastic, being over-active and easily irritated or distracted) caused by bipolar disorder. Bipolar disorder is where the mood changes between feeling very high (mania) and very low (depression).

Syonell can be used only if nothing else has worked for you.

2. What you need to know before you take Syonell

Do not take Syonell if:

• You are allergic (hypersensitive) to valproate semisodium or any of the other

  ingredients of Syonell (listed in section 6).

  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,

  especially if caused by taking a medicine.

• You have a rare illness called porphyria which affects your metabolism. • You have a known metabolic disorder, i.e. a urea cycle disorder. • You have a genetic problem caused by a mitochondrial disorder (e.g. Alpers-

  Huttenlocher syndrome).

• You have a deficiency in carnitine (a very rare metabolic disease) that is untreated. • You are pregnant (see 'Pregnancy, breast-feeding and fertility - Important advice for

  women' below).

• If you are a woman aged under 55 years who is able to have a baby, you must not take

  Syonell unless two specialists have agreed that your condition does not respond to other treatments and the benefits of treatment outweigh the risks and you use an effective method of birth control (contraception) at all times during your entire treatment with Syonell. Do not stop taking Syonell or your contraception until you have discussed this with your specialist. Your specialist will advise you further (see below under 'Pregnancy, breast-feeding and fertility – Important advice for women'). Do not take this medicine if any of the above apply to you. If you are not sure, talk to your GP, specialist or pharmacist before taking Syonell.

Warnings and precautions

• The risk of liver damage is increased if Syonell is taken by children under 3 years of

  age, in people taking antiepileptic medicine at the same time or having other neurological or metabolic disease and severe forms of epilepsy. • A small number of people being treated with mood stabilisers such as valproate

  semisodium have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your GP or specialist. • In patients with epilepsy, convulsions may become worse or happen more frequently

  whilst taking this medicine. If this happens contact your GP or specialist immediately. • If you or your child taking Syonell develops problems with balance and co-ordination,

  feeling lethargic or less alert, vomiting, tell your doctor immediately. This may be due to increased amount of ammonia in the blood.

• Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal

  necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), erythema multiforme and angioedema have been reported in association with valproate treatment. Seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4. Talk to your GP, specialist or pharmacist before taking Syonell if:

• You are changing from another medicine that contains valproate. • The person taking this medicine is less than 18 years old.
• You have fits (epilepsy), a brain disease or a metabolic condition affecting your brain. • You have problems with your pancreas.

• You have diabetes or are being tested for diabetes. This medicine may affect the

  results of urine tests.

• You know or your doctor suspects that there is a genetic problem caused by a

  mitochondrial disorder in your family, because of a risk of damage to your liver. • You are suspected to suffer from any metabolic disorders, particularly hereditary

  enzyme deficiency disorders such as a “urea cycle disorder” because of a risk of increased ammonia level in the blood.

• You have a rare disorder named 'carnitine palmitoyltransferase type II deficiency',

  because you are at an increased risk of muscle disorders.

  • You have impaired dietary intake in carnitine, found in meat and dairy products,

    especially in children less than 10 years old.

  • You have a deficiency in carnitine and are taking carnitine.

  • You have kidney problems. Your specialist may monitor your valproate level or adjust

    your dose.

  • You have an illness called 'systemic lupus erythematosus (SLE)' - a rare disease of

    the immune system which affects the skin, bones, joints and internal organs. • You have ever developed a severe skin rash or skin peeling, blistering and/or mouth

    sores after taking valproate.

If you are not sure if any of the above apply to you, talk to your GP, specialist or pharmacist before taking Syonell.

Weight gain

Taking Syonell may make you put on weight. Talk to your GP, specialist or pharmacist about how this will affect you.

Blood tests

Your GP and/or specialist may request regular blood tests and liver function tests before and during your treatment with this medicine. Syonell can change the levels of liver enzymes shown in blood tests. This can mean that your liver is not working properly. Other medicines and Syonell

Tell your GP, specialist or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Syonell can affect the way some other medicines work. Also, some medicines can affect the way Syonell works.

In particular, check with your GP, specialist or pharmacist if you are taking any of the following:

• Some medicines used for pain and inflammation (salicylates) such as aspirin. • Some medicines used to treat fits (epilepsy) such as phenobarbital, primidone,

  phenytoin, carbamazepine, rufinamide, topiramate, acetazolamide, lamotrigine and felbamate. Your doctor may change the dose of one of your medicines and monitor your treatment closely.

• Cannabidiol (used to treat epilepsy and other conditions).

• Medicines used to calm emotional and mental health disorders (including

  schizophrenia, bipolar disorder and depression) such as quetiapine, diazepam and olanzapine.

• Monoamine oxidase inhibitors (MAOIs) such as moclobemide (used to treat

  depression and anxiety), selegiline (used to treat Parkinson's disease), linezolid (used to treat infections).

• Anticoagulants such as warfarin – used to thin the blood and prevent clots. Your

  doctor may change your dose of the blood thinning medicine and monitor your treatment closely.

• Zidovudine and protease inhibitors such as lopinavir and ritonavir - used to treat HIV

  infection and AIDs.

• Carbapenem agents (antibiotics used to treat bacterial infections) such as

  panipenem, imipenem, meropenem, rifampicin and erythromycin. The combination of Syonell and carbapenems should be avoided because it may decrease the effect of your medicine.

• Some anti-infectives that contain pivalate (e.g., pivampicillin, adefovir dipivoxil). • Some medicines used to treat or prevent malaria such as mefloquine or chloroquine. • Temozolomide - used to treat cancer.
• Cimetidine - used to treat stomach ulcers.
• Cholestyramine - used to lower blood fat (cholesterol) levels.
• Nimodipine - used to treat bleeding in the brain (subarachnoid haemorrhage). • Propofol - used for anaesthesia.
• Oestrogen-containing products (including some birth control pills). • Metamizole - used to treat pain and fever.
• Methotrexate - used to treat cancer and inflammatory diseases. • Clozapine – used to treat mental health conditions

Syonell with alcohol

Alcohol intake is not recommended during treatment.

Pregnancy, breast-feeding and fertility

Important advice for female patients aged under 55 years

• You must not use Syonell if you are pregnant.

• If you are a female patient aged under 55 years, you must not take Syonell, unless two

  specialists have agreed that your condition does not respond to other treatments and the benefits of treatment outweigh the risks. If you are able to have a baby, you must use an effective method of birth control (contraception) at all times during your entire treatment with Syonell.

• Do not stop taking Syonell or your birth control (contraception) until you have

  discussed this with your specialist. Your specialist will advise you further. The risks of valproate when taken during pregnancy

• Contact your GP immediately if you are planning to have a baby or are pregnant. Your

  GP will urgently refer you to your specialist.

• Valproate carries a risk if taken during pregnancy. The higher the dose, the higher the

  risks but all doses carry a risk, including when valproate is used in combination with other medicines to treat epilepsy.

• It can cause serious birth defects and can affect the physical and mental development

  of the child as it grows after birth and may lead to permanent disability. 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 11 babies in every 100 will have birth defects. This compares to 2-3 babies in every 100 born to women from the general population.

  • The most frequently reported birth defects 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 and multiple associated malformations affecting several organs and parts of the body. Birth defects may result in disabilities which may be severe and/or permanent.

  • Hearing problems or deafness have been reported in children exposed to

    valproate during pregnancy.

  • Eye malformations have been reported in children exposed to valproate during

    pregnancy in association with other congenital malformations. These eye malformations may affect vision.

• It is estimated that up to 30-40% of 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.

  • Autism and related disorders are more often diagnosed in children exposed to

    valproate during pregnancy and there is some evidence that children exposed to valproate during pregnancy are at increased risk of developing Attention Deficit Hyperactivity Disorder (ADHD).

  • If you take valproate during pregnancy, your baby may have a lower weight than

    expected for their age at birth.

    • Before prescribing this medicine to you, two specialists will have agreed that your condition does not respond to other treatments and the benefits of treatment outweigh the risks, and your specialists will have explained what might happen to your baby if you become pregnant whilst taking valproate.
    • If you decide later that you want to have a baby, you must not stop taking your medicine or your method of birth control (contraception) until you have discussed this with your specialist.
    • Some birth control pills (oestrogen-containing birth control pills) may lower valproate levels in your blood. Make sure you talk to your GP, specialist or sexual health and contraception clinic about the method of birth control (contraception) that is the most appropriate for you.
    • Ask your specialist about taking folic acid when planning to have 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.

Please choose the situations which apply to you and read the descriptions below:

• I AM STARTING TREATMENT WITH SYONELL
• I AM TAKING SYONELL AND NOT PLANNING TO HAVE A BABY
• I AM TAKING SYONELL AND PLANNING TO HAVE A BABY
• I AM PREGNANT AND I AM TAKING SYONELL

I AM STARTING TREATMENT WITH SYONELL

If you are a female patient aged under 55 years who is able to have a baby, this medicine can only be prescribed for you if two specialists have agreed that your condition does not respond to other treatments and the benefits of treatment outweigh the risks. If this is the first time you have been prescribed Syonell, your specialist will have explained the risks to an unborn child if you become pregnant. If you are able to have a baby, you must use an effective method of birth control (contraception) at all times during your entire treatment with Syonell. Talk to your GP, specialist or sexual health and contraception clinic if you need advice on birth control (contraception).

Key messages:

• Pregnancy must be excluded before start of treatment with Syonell with the result of a pregnancy test, confirmed by your specialist.
• You must use an effective method of birth control (contraception) at all times during your entire treatment with Syonell.

• You must discuss appropriate and effective methods of birth control (contraception)

  with your GP or specialist. Your GP or specialist will give you information on preventing pregnancy and may refer you to a specialist for advice on birth control (contraception).

• You must get regular (at least annual) appointments with a specialist experienced in the management of bipolar disorder. During this visit your specialist will reassess whether you should continue receiving treatment with valproate or whether another medicine should be prescribed. The specialist will make sure you are well aware of and have understood all the risks and advice related to the use of valproate during pregnancy.
• Tell your specialist if you want to have a baby.
• Tell your specialist immediately if you are pregnant or think you might be pregnant. I AM TAKING SYONELL AND NOT PLANNING TO HAVE A BABY

If you are a female patient aged under 55 years who is able to have a baby, this medicine can only be prescribed for you if two specialists have agreed that your condition does not respond to other treatments and the benefits of treatment outweigh the risks. If you are continuing treatment with Syonell and you don't plan to have a baby, you must use an effective method of birth control (contraception) at all times during your entire treatment with Syonell. Talk to your GP, specialist or sexual health and contraception clinic if you need advice on birth control (contraception).

Key messages:

• You must use an effective method of birth control (contraception) at all times during your entire treatment with Syonell.

• You must discuss appropriate and effective methods of birth control (contraception)

  with your GP or specialist. They will give you information on preventing pregnancy and may refer you to a specialist for advice on birth control (contraception). • You must get regular (at least annual) appointments with a specialist experienced in the management of bipolar disorder. During this visit your specialist will reassess whether you should continue receiving treatment with valproate or whether another medicine should be prescribed. The specialist will make sure you are well aware of and have understood all the risks and advice related to the use of valproate during pregnancy.

• Tell your GP or specialist if you want to have a baby.
• Tell your specialist, or GP to be urgently referred to your specialist, immediately if you are pregnant or think you might be pregnant.

I AM TAKING SYONELL AND PLANNING TO HAVE A BABY

If you are planning to have a baby, first schedule an appointment with your GP. Your GP will urgently refer you to your specialist.

Do not stop taking Syonell or your birth control (contraception) until you have discussed this with your specialist. Your specialist will advise you further.

Babies born to mothers who have been on valproate are at serious risk of birth defects and problems with development (behaviour and learning disorders) which can be seriously debilitating and/or permanent. Babies are also at risk of lower weight than expected for their age at birth. Your GP will refer you to a specialist experienced in the management of bipolar disorder so that other treatment options are evaluated early on. Your specialist 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.

You must not use Syonell if you are pregnant. Your specialist may decide to switch you to another medicine and stop treatment with Syonell a long time before you become pregnant – this is to make sure your illness is stable.

Ask your specialist about taking folic acid when planning to have 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 taking Syonell unless your specialist tells you to.
• Do not stop using your method of birth control (contraception) before you have talked to your specialist and worked together on a plan to ensure your condition is controlled and the risks to you and your baby are reduced.
• First schedule an appointment with your specialist. During this visit your specialist will reassess whether you should continue receiving treatment with valproate or whether another medicine should be prescribed. They will make sure you are well aware of and have understood all the risks and advice related to the use of valproate during pregnancy.

• Your specialist will try to switch you to another medicine or stop treatment with

  Syonell a long time before you become pregnant.

• Schedule an urgent appointment with your GP to be urgently referred to your specialist, immediately if you are pregnant or think you might be pregnant. Syonell 250mg Gastro-Resistant tablets Syonell 500mg Gastro-Resistant tablets

284929

11176

284929 LFLT SYONELL GR TABS UK R12 (FRONT)

WARNING

Syonell, valproate semisodium, can seriously harm an unborn child when taken during pregnancy. If you are a female able to have a baby, you must use an effective method of birth control (contraception) at all times during your entire treatment with Syonell. Your specialist will discuss this with you, but you should also follow the advice in section 2 of this leaflet.

Schedule an urgent appointment with your general practitioner (GP) for a referral to a specialist if you want to become pregnant or think you are pregnant. Do not stop taking Syonell unless your specialist tells you to as your condition may become worse.

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Dieline (Does Not Print) I AM PREGNANT AND I AM TAKING SYONELL

Do not stop taking Syonell, unless your specialist tells you to as your condition may become worse.

Schedule an urgent appointment with your GP. Your GP will refer you immediately to your specialist if you are pregnant or think you might be pregnant. Your specialist will then advise you further.

Babies born to mothers who have been on valproate are at serious risk of birth defects and problems with development (behaviour and learning disorders) which can be seriously debilitating and/or permanent. Babies are also at risk of lower weight than expected for their age at birth. Your GP will refer you to your specialist experienced in the management of bipolar disorder so that other treatment options can be evaluated. You and your partner should receive counselling and support regarding the valproate-exposed pregnancy. Ask your specialist 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:

• Schedule an urgent appointment with your GP. Your GP will refer you immediately to

  your specialist if you are pregnant or think you might be pregnant. Your specialist will then advise you further.

• Do not stop taking Syonell unless your specialist tells you to.

• Make sure you are referred to a specialist experienced in the treatment of bipolar

  disorder to evaluate the other treatment options.

• You must get thorough counselling on the risks of Syonell during pregnancy,

  including malformations and physical and mental development disorders in children. • Make sure you are referred to a specialist for prenatal monitoring to examine for

  potential malformations.

Make sure you read the Patient Guide that you will receive from your specialist, GP or pharmacist. If you are a female of childbearing potential, your specialist will discuss and complete the Annual Risk Acknowledgement Form with you and will ask you to sign it and keep it. You will also receive a Patient Card from your pharmacist to remind you of valproate risks in pregnancy.

Newborn babies of mothers who took valproate during pregnancy may have:

• Blood clotting problems (such as blood not clotting very well). This may appear as

  bruising or bleeding which takes a long time to stop.

• Hypoglycaemia (low blood sugar).

• Hypothyroidism (underactive thyroid gland, which can cause tiredness or weight

  gain).

• Withdrawal syndrome (including agitation, irritability, hyperexcitability, jitteriness,

  hyperkinesia, muscle problems, tremor, convulsions and feeding problems). In particular, this may occur in newborns whose mothers have taken valproate during the last trimester of their pregnancy.

Breast-feeding

Very little Syonell gets into the breast milk. However, talk to your GP or specialist about whether you should breast-feed your baby. Ask your GP, specialist or pharmacist for advice before taking any medicine.

Important advice for male patients

• If you are a male aged under 55 years, before prescribing this medicine to you for the

  first time, two specialists will have agreed that your condition does not respond to other treatments or the risk to fertility does not apply to you.

• Your specialist will have explained to you the known risk of male infertility (see

  section 4 Possible side effects) and the potential risk in children born to fathers treated with valproate.

• If you are a parent or a caregiver of a male child treated with valproate, a specialist will

  explain to you that there are studies showing toxic effects of valproate on the testes of animals receiving the medicine and it is unclear what this means for humans. Potential risks related to taking valproate in the 3 months before conception of a child A study suggests a possible risk of neurodevelopmental conditions (problems with early childhood development) in children born to fathers treated with valproate in the 3 months before conception. In this study, around 5 children in 100 had such disorders when born to fathers treated with valproate as compared to around 3 children in 100 when born to fathers treated with lamotrigine or levetiracetam (other medicines that can be used to treat your disease).

Other studies did not suggest an increased risk of mental developmental disorders (problems with early childhood development) in children born to fathers treated with valproate in the 3-4 months before conception. In these studies the risk was similar compared to children of fathers treated with lamotrigine or levetiracetam before conception.

Differences in how these studies were designed may explain the different results. Overall, it is not known whether any possible risk of childhood developmental disorders is caused by valproate itself or by other factors, such as the father's underlying medical condition. As a precautionary measure, your GP or specialist will discuss with you: • The potential risk in children born to fathers treated with valproate • The need to consider effective contraception (birth control) for you and your female

partner during treatment and for 3 months after stopping treatment • The need to consult your specialist when you are planning to conceive a child and

before stopping contraception (birth control)

• The possibility of other treatments that can be used to treat your disease, depending

  on your individual situation

Do not donate sperm when taking valproate or for 3 months after stopping valproate. Talk to your GP or specialist if you are thinking about having a baby.

If your female partner becomes pregnant while you used valproate in the 3 months period before conception and you have questions, contact your GP or specialist. Do not stop your treatment without talking to your GP or specialist. If you stop your treatment, your symptoms may become worse.

You should get regular appointments with your GP. During this visit your GP will discuss with you the precautions associated with valproate use. They will refer you to a specialist to discuss the possibility of other treatments that can be used to treat your disease, depending on your individual situation.

Make sure you read the Patient Guide that you will receive from your specialist, GP or pharmacist. If you are a male patient aged under 55 years starting treatment with valproate, your specialist will discuss and complete a risk acknowledgement form with you and will ask you to sign it and keep it.

Driving and using machines

You may feel sleepy, confused or dizzy while taking this medicine. If this happens, do not drive or use any tools or machines.

Syonell contains sodium:

• Syonell 250 mg Gastro-Resistant tablets contains 18.51 mg sodium (main

  component of cooking/table salt) in each tablet. This is equivalent to 0.9% of the recommended maximum daily dietary intake of sodium for an adult per tablet. • Syonell 500 mg Gastro-Resistant tablets contains 37.03 mg sodium (main

  component of cooking/table salt) in each tablet. This is equivalent to 1.8% of the

  recommended maximum daily dietary intake of sodium for an adult per tablet.

3. How to take Syonell

Always take Syonell exactly as your specialist has told you. Check with your specialist, GP or pharmacist if you are not sure.

Syonell treatment must be started and supervised by a specialist experienced in the treatment of bipolar disorders.

Your specialist will decide your daily dose. If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your GP or specialist. How to take your medicine

• Take this medicine by mouth

• Swallow the tablets whole with a drink of water. Do not crush or chew them. • Take Syonell with or after food. This will help to stop the feelings of sickness that may

  happen after taking Syonell.

How much to take

Adults (including the elderly)

• Starting dose is 750 mg on the first day. This is usually taken as 2 or 3 divided doses. • The usual dose is then increased to 1000 mg-2000 mg each day.
• Your specialist may decide to increase your dose depending on your illness. Patients with kidney problems
• Your specialist may decide to adjust your dose.

Children and adolescents

• Syonell should not be used in children and adolescents under 18 years of age for the

  treatment of mania.

If you take more Syonell than you should

If you or someone else has taken more Syonell than you should, contact your GP or specialist urgently or go to your nearest hospital casualty department immediately. Remember to take the medicine pack with you. This is so the doctor knows what you have taken.

The following effects may happen: feeling sick or being sick, headache, blurred eyesight due to pupil of the eye becoming smaller, dizziness, poor reflexes, confusion, memory loss and tiredness. You may also have weak or 'floppy' muscles, fits (seizures), loss of consciousness, behavioural changes and breathing difficulties such as fast breathing, shortness of breath or chest pain.

If you forget to take Syonell

If you forget to take a dose at the right time, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose.

If you stop taking Syonell

Do not stop taking Syonell or alter your dose without checking with your specialist. If you stop taking Syonell without your specialist's advice, your condition may get worse. When your specialist says that you can stop taking Syonell, your dose will be lowered gradually. Your specialist will help you to do this.

Tests

Make sure you keep your regular appointments for a check-up. They are very important as your dose may need to be changed. If you go into hospital or visit another doctor or a dentist, tell them you are taking Syonell.

If you have any further questions on the use of this product, ask your GP, specialist or pharmacist.

4. Possible side effects

Like all medicines, Syonell can cause side effects, although not everybody gets them. Side effects are more likely to happen at the start of treatment.

Tell your GP, specialist or go to a hospital straight away if you notice any of the following serious side effects – you may need urgent medical treatment:

• You have an allergic reaction which may manifest as:

  • Blisters with skin detachment (blistering, peeling or bleeding on any part of your

    skin (including your lips, eyes, mouth, nose, genitals, hands or feet) with or without rash), sometimes with flu-like symptoms such as fever, chills or aching muscles. These may be signs of conditions named 'Toxic epidermal necrolysis' or 'Stevens-Johnson Syndrome'.

  • 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 may be signs of a condition named 'erythema multiforme'.

  • Allergy-triggered swelling with painful itchy welts (most often around the eyes,

    lips, throat and sometimes hands and feet) and swallowing or breathing problems. These may be signs of 'angioedema' or an anaphylactic reaction.

  • Syndrome with skin rash, fever, lymph node enlargement and possible

    impairment of other organs. These may be signs of a condition named 'Drug Rash with Eosinophilia and Systemic Symptoms (DRESS)'. • Liver problems or 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 Syonell. It includes feeling sick (nausea) and being sick (vomiting) many times; extreme tiredness, drowsiness and weakness; stomach pain including severe upper stomach pain; yellowing of the skin or whites of the eyes (jaundice); loss of appetite; swelling of the legs and feet (may also include other parts of the body); recurrence of fits (seizures) for patients with epilepsy or a general feeling of being unwell. Your doctor may tell you to stop taking Syonell immediately if you have these symptoms.

• Blood disorders that can be shown in blood tests. Signs may include:

  • Spontaneous bruising or bleeding due to blood clotting problems or decreased

    platelet count, or getting more infections than usual (thrombocytopenia)

  • Severe decrease of white blood cells or bone marrow failure, sometimes

    revealed by fever and breathing difficulty (agranulocytosis)

  • Decreased red blood cell count (anaemia) or abnormally increased red blood cell

    size (macrocytosis)

  • Bone marrow disorders that affect red blood cells, white blood cells and platelets

    (pancytopenia)

• Drowsiness, change in consciousness level (including coma), confusion, loss of

  memory, abnormal behaviour including changes in attention, concentration and mood. This could also be associated with hallucinations or fits (seizures). This is more likely if medicine to treat fits such as phenobarbital and topiramate are taken at the same time or if the Syonell starting dose is high or has been suddenly increased. • Shakiness (tremor), jerky muscle movements, unsteadiness when walking

  (parkinsonism, extrapyramidal disorder, ataxia).

• Problems with balance and co-ordination, feeling lethargic or less alert, associated

  with being sick (vomiting). This may be due to an increased amount of ammonia in your blood.

• Underactive thyroid gland, which may cause tiredness or weight gain

  (hypothyroidism)

• Difficulty breathing, pain or pressure in the chest (especially when breathing in),

  shortness of breath and dry cough due to buildup of fluid around the lungs (pleural effusion)

  • Rapid, uncontrollable movement of the eyes
  • An increase in the number and severity of convulsions in patients with epilepsy • Muscle pain and weakness (rhabdomyolysis)
  • Joint pain, fever, fatigue or rash. These may be signs of systemic lupus erythematosus (SLE).

  • Kidney disease or kidney problems (renal failure, tubulointerstitial nephritis and

    Fanconi syndrome) which may manifest as reduced urinary output or blood in the urine

  • Confusion, that could be due to decreased levels of sodium in your blood, identified by a blood test, or to a condition named 'Syndrome of Inappropriate Antidiuretic Hormone (SIADH) secretion’

Tell your GP, specialist or pharmacist if any of the following side effects get serious or lasts longer than a few days:

• Feeling sick (nausea), being sick (vomiting), stomach ache or diarrhoea, especially when starting treatment. This may be helped by taking the tablets with food. • Overgrowth of gums (gingival hypertrophia), swelling of gums or mouth, sore mouth, mouth ulcers and burning feeling of mouth (stomatitis)
• Headache
• Hearing loss, hearing problems or deafness
• Double vision
• Nail and nail bed disorders
• Skin problems such as rashes. These happen rarely, but more often in people also taking lamotrigine.
• Transient hair loss, abnormal hair growth, abnormal hair texture, changes in hair
• Darker areas of skin and mucosae (hyperpigmentation)
• Increased levels of some hormones (androgens), which may lead to increased hair growth on the face, breasts or chest (particularly in women), acne or thinning hair. • Skin rash caused by inflammation of small blood vessels (vasculitis) • Irregularity or absence of women's period, pain during women's period, cysts in the ovaries (polycystic ovaries)
• Breast enlargement in men, male infertility (usually reversible after treatment discontinuation and may be reversible after dose reduction. Do not stop your treatment without speaking to your specialist first)
• Bedwetting or increased need to pass urine, urinary incontinence (unintentional passing of urine)
• Passing a lot of urine and feeling thirsty (Fanconi syndrome)
• Decrease in carnitine levels (shown in blood or muscular tests)
• Swelling of the feet and legs (oedema)
• Obesity, weight gain – as your appetite may be increased
• Seeing, feeling or hearing things that are not there (hallucinations) • Aggression, agitation, disturbance in attention, abnormal behaviour, restlessness/hyperactivity, memory impairment, or cognitive or learning disorder • Tingling or numbness in the hands and feet
• Lowering of normal body temperature

There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures. Check with your GP, specialist or pharmacist if you are on long-term anti-epileptic medication, have a history of osteoporosis, or take steroids.

Tests

Syonell can change levels of liver enzymes, blood clotting factors, salts or sugars shown up on blood and urine tests.

Additional side effects in children

Some side effects of valproate occur more frequently in children or are more severe compared to adults. These include liver damage, inflammation of the pancreas (pancreatitis), bedwetting (enuresis), renal dysfunction (Fanconi Syndrome), overgrowth of gum tissue, aggression, agitation, disturbance in attention, abnormal behaviour, hyperactivity and learning disorder.

Reporting of side effects

If you get any side effects, talk to your GP, specialist, 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 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 Syonell

Keep this medicine out of the sight and reach of children.

Do not use Syonell after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.

Syonell should be stored below 25°C.

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 protect the environment.

6. Contents of the pack and other information

What Syonell contains

Each oval, pink coloured, gastro-resistant 250 mg tablet contains 269.1 mg valproate semisodium (equivalent to 250 mg valproic acid) as the active ingredient. Each oval, pink coloured, gastro-resistant 500 mg tablet contains 538.1 mg valproate semisodium (equivalent to 500 mg valproic acid) as the active ingredient. Syonell also contains the following inactive ingredients:

Microcrystalline cellulose, pregelatinised starch, colloidal silicone dioxide, magnesium stearate, low-substituted hydroxypropylcellulose, Opadry White, hypromellose phthalate, triethyl citrate, titanium dioxide (E171) and vanillin.

Syonell are coloured with Allura Red FD&C 40 (E129) and Indigo Carmine FD&C Blue 2 (E132), marked with Opacode Black S-1-17823 (ink) and available in blister packs of 30, 60 and 90 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Lupin Healthcare (UK) Limited

The Urban Building, 2nd floor,

3-9 Albert Street, Slough, Berkshire,

SL1 2BE, United Kingdom.

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your GP, specialist or pharmacist. This leaflet was last revised in August 2026

Code No.: GO/DRUGS/654 ID#: 284929

284929 LFLT SYONELL GR TABS UK R12 (BACK)