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

1. WHAT BELVO IS AND WHAT IT IS USED FOR

Belvo 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.

Belvo 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).

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

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BELVO

Do not take Belvo

• If you are allergic (hypersensitive) to valproate semisodium,

  other medicines containing valproic acid or any of the other

  ingredients of this medicine (listed in section 6). Signs of an

  allergic reaction include: a rash, swallowing or breathing

  problems, swelling of your lips, face, throat or tongue.

• If you have a liver problems, acute or chronic hepatitis

  (inflammation of the liver) or your family have a history of

  liver problems, especially if caused by taking a medicine.

• If you have a rare illness called porphyria which affects your

  metabolism.

• If you have a known metabolic disorder i.e. a urea cycle

  disorder.

• If you have a genetic problem caused by a mitochondrial

  disorder (e.g. Alpers-Huttenlocher syndrome).

• If you have a deficiency in carnitine (a very rare metabolic

  disease) that is untreated.

• You must not use Belvo if you are pregnant ‘Pregnancy,

  breast-feeding and fertility – Important advice for women’

  below).

• If you are a woman under the age of 55 years who is able to

  have a baby, you must not take Belvo, unless two different

  specialists have agreed that your condition does not respond

  to other treatments and the benefits of treatment outweigh

  the risks and you use effective method of birth control

  (contraception) at all times during your entire treatment with

  Belvo. Do not stop taking Belvo 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 specialist, GP or pharmacist

before taking Belvo.

Warnings and precautions

• The risk of liver damage is increased if Belvo 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 Belvo 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 specialist, GP or pharmacist before taking Belvo:

• If you have problems with your pancreas

• If you have diabetes or are being tested for diabetes. This

  medicine may affect the results of urine tests.

• If you know or your doctor suspects that there is a genetic

  problem caused by mitochondrial disorder in your family,

  because of a risk of damage to your liver.

• If 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.

• If you have a rare disorder named ‘carnitine

  palmitoyltransferase type II deficiency’, because you are at

  an increased risk of muscle disorders.

• If you have impaired dietary intake in carnitine, found in

  meat and dairy products, especially in children less than 10

  years old.

• If you have a deficiency in carnitine and are taking carnitine.

• If you have an illness ‘systemic lupus erythematosus (SLE)’ –

  a rare disease of the immune system which affects skin,

  bones, joints and internal organs.

• If you have kidney problems. Your specialist may monitor

  your valproate level or adjust your dose.

• 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.

• If 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 Belvo.

Weight gain

Taking Belvo may make you put on weight. Talk to your

specialist, GP 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. Belvo can change the levels of liver enzymes shown

up in blood tests. This can mean that your liver is not working

properly.

Other medicines and Belvo

• 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 Belvo can affect the way

  some other medicines work. Also, some medicines can

  affect the way Belvo works.

In particular, check with your GP, specialist or pharmacist if you

are taking any of the following:

• 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 Belvo 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 for pain and inflammation (salicylates)

  such as aspirin.

• 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).

Belvo with food, drink and alcohol

Alcohol intake is not recommended during treatment.

Pregnancy, breast-feeding and fertility

Important advice for female patients under the age of

55 years

• You must not use Belvo if you are pregnant.

• If you are female patient under the age of 55 years you must

  not take Belvo, 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 Belvo.

• Do not stop taking Belvo 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 a 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 to 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.
  • Eye malformations have been reported in children exposed to valproate during pregnancy in association with other congenital malformations. These eye malformations may affect vision.
  • Hearing problems or deafness have been reported in children exposed to valproate during pregnancy.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.
  • 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 contraception until you have discussed this with your doctor.
  • If you are a parent or a caregiver of a female child treated with valproate, you should contact the GP once your child using valproate experiences their first period (menarche). Their GP will refer your child to their specialist who will decide with another specialist whether valproate is the only possible treatment and if not will try to switch your child to another medicine.
  • 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 contraception (birth control) 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 and read the situations which apply to you from the situations described below:

O I AM STARTING TREATMENT WITH BELVO

O I AM TAKING BELVO AND NOT PLANNING TO HAVE A BABY O I AM TAKING BELVO AND PLANNING TO HAVE A BABY O I AM PREGNANT AND I AM TAKING BELVO

I AM STARTING TREATMENT WITH BELVO

If you are a girl or a woman under the age of 55 years who is able to have a baby, this medicine can only be prescribed for you if two different 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 Belvo 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 treatment with Belvo. Talk to your GP, specialist or sexual health and contraception clinic if you need advice on contraception.

Key messages:

• Pregnancy must be excluded before start of treatment with Belvo 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 Belvo.
• You must discuss the 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.
• 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 BELVO AND NOT PLANNING TO HAVE A BABY

If you are a female patient under the age of 55 years who is able to have a baby, this medicine can only be prescribed for you if two different specialists have agreed that your condition does not respond to other treatments and the benefits of the treatment outweigh the risks. If you are continuing treatment with Belvo and you are not planning to have a baby you must use an effective method of birth control (contraception) at all times during your entire treatment with Belvo. 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 Belvo.
• You must discuss appropriate and effective methods of birth control (contraception) with your GP, specialist. Your specialist will give you information on preventing pregnancy, and may refer you to a specialist for advice on birth control.
• 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. They will make sure you are well aware 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 BELVO 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 Belvo or your 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 (behavior 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 can be 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 Belvo if you are pregnant. Your specialist may decide to switch you to another medicine and stop treatment with Belvo 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 Belvo unless your doctor tells you to.
• Do not stop using your methods of birth control (contraception) before you have talked to your doctor 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 and have understood all the risks and advices related to the use of valproate during pregnancy.
• Your specialist will try to switch you to another medicine, or stop treatment with Belvo a long time before you become pregnant.
• Schedule an urgent appointment with your specialist, or GP to be urgently referred to your specialist, immediately if you are pregnant or think you might be pregnant.

I AM PREGNANT AND I AM TAKING BELVO

Do not stop taking Belvo, 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 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 can be evaluated.

You and your partner could 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 Belvo unless your specialist tells you to. WARNING

Belvo, 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 effective method of birth control (contraception) without interruptions during your entire treatment with Belvo. Your specialist will discuss this with you but you must 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 if you think you are pregnant.

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• Make sure you are referred to a specialist experienced in the treatment of bipolar disorder to evaluate the need for other treatment options.
• You must get thorough counselling on the risks of Belvo 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 Belvo 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 treatment valproate, a specialist will explain to you that there are studies showing toxic effects of valproate on the testes of animals receiving valproate 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 mental and movement related developmental disorders (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 use 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 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.

Belvo 250 mg gastro-resistant tablets contains Sunset yellow (E110) and Belvo 500 mg gastro-resistant tablets contains Carmoisine (E122) and Ponceau 4R (E124) that may cause allergic reactions.

Belvo contains sodium

Belvo 250 mg gastro-resistant tablets: this medicine contains less than 1 mmol sodium per tablet, that is to say essentially ‘sodium-free’.

Belvo 500 mg gastro-resistant tablets: this medicine contains 37.0 mg sodium (main component of cooking/table salt) in each tablet. This is equivalent to 1.85% of the recommended maximum daily dietary intake of sodium for an adult.

3. HOW TO TAKE BELVO

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

Belvo 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 Belvo with or after food. This will help to stop the feelings of sickness that may happen after taking Belvo.

How much to take

Adults (including the elderly)

• Starting dose is 750mg on the first day. This is usually taken as 2 or 3 divided doses.
• The usual dose is then increased to 1000-2000mg 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

• Belvo should not be used in children and adolescents under 18 years of age for the treatment of mania.

If you take more Belvo than you should

Talk to your GP or specialist or go to your nearest hospital casualty department straight away.

Remember to take the medicine pack with you. This is so the doctor knows what you have taken. Do not drive to the hospital, get somebody else to take you or call for an ambulance.

If you took the medicine less than two hours ago, try to induce vomiting.

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 Belvo

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 Belvo

Do not stop taking Belvo or alter your dose without checking with your specialist. If you stop taking Belvo without your specialist’s advice, your condition may get worse. When your specialist says that you can stop taking Belvo, 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 Belvo.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine 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 Belvo. It includes feeling sick (nausea) and being sick

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(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 Belvo 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 Belvo 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 colour
• 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)
• Darker areas of skin and mucosae (hyperpigmentation)
• 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)
• Bed wetting 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 antiepileptic medication, have a history of osteoporosis, or take steroids.

Tests

Belvo 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 Website: 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 BELVO

Do not store above 25°C.

Keep the blister in the outer carton in order to protect from light and moisture.

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 carton after “EXP”. The expiry date refers to the last day of that month.

Do not take this medicine if you notice visible signs of deterioration in the tablets.

Do not throw away any medicines via wastewater or household waste. Ask your GP, specialist or 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 Belvo contains

• The active substance is valproate semisodium.
• The other excipients are:

Belvo 250 mg gastro-resistant tablets:

silicon dioxide, pregelatinized starch, povidone, titanium dioxide (E171), talc, hypromellose phthalate, diacetylated monoglycerides, Yellow Aluminium Lake (Sunset yellow (E110) and Aluminium), vanillin.

Belvo 500 mg gastro-resistant tablets:

silicon dioxide, pregelatinized starch, povidone, titanium dioxide (E171), talc, hypromellose phthalate, diacetylated monoglycerides, Carmoisine lake (Carmoisine (E122) and Aluminium), Ponceau 4R lake (Ponceau 4R (E124) and Aluminium), vanillin.

What Belvo looks like and contents of the pack

Belvo 250 mg consists of peach oblong gastro-resistant tablets without inscriptions.

Belvo 500 mg consists of pink oblong

gastro-resistant tablets.

The tablets are packed in Aluminium/PVDC+PVC/PE/PVDC. Packs of 20, 30, 60 and 90 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer: Marketing Authorization Holder:

Consilient Health Limited

Floor 3, Block 3, Miesian Plaza,

Dublin 2, D02 Y754, Ireland.

Manufacturer:

Lusomedicamenta – Sociedade Técnica Farmacêutica, Lda. Estrada Consiglieri Pedroso, 69-B – Queluz de Baixo 2730-055 Barcarena, Portugal

This leaflet was last revised in July 2026.

Other sources of information

For the most up to date patient information leaflet and important safety information on this product for all patients, scan the QR code included in this leaflet with a smartphone. The same information is also available on the following URL: consilienthealth.co.uk/belvo-patient-landing-page

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