Navalpro 400 mg/4 ml Solution

NAVALPRO 400 mg/4 ml contains a medicine called sodium valproate. This belongs to a group of medicines called anticonvulsants or antiepileptic medicines. NAVALPRO 400 mg/4 ml is used to treat epilepsy (fits) in adults and children. The injection is given when it is not possible to have your medicine by mouth.

NAVALPRO 400 mg/4 ml should not be administered to you:

• if you are allergic (hypersensitive) to sodium valproate or any of the other ingredients of NAVALPRO 400 mg/4 ml (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 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 are breastfeeding your baby (see section titled Pregnancy, breastfeeding and fertility).
• if you are pregnant - For the treatment of epilepsy:
• if you or your female (girl) child are pregnant, unless there is no suitable alternative treatment (see section titled Pregnancy, breastfeeding and fertility).
• if you or your female (girl) child are able to have a baby, unless you use an effective method of birth control (contraception) at all times during your treatment with NAVALPRO INJECTION 400 mg/4 ml and the conditions of the pregnancy prevention programme are met (see section titled Pregnancy, breastfeeding and fertility).
• If you or your child have an active disease of the liver, including the following:
• if you or your child have short or long-term (severe) hepatitis (inflammation of the liver).
• if you or your child (or any of your close relatives) have a past history of severe hepatitis (inflammation of the liver), especially when caused by medicines.
• if you or your child suffer from liver porphyria (a rare metabolic disease caused by problems with how your body makes a substance called heme, a component of hemoglobin, the red pigment in blood).

Warnings and precautions

Tell your doctor or healthcare provider before being given NAVALPRO 400 mg/4 ml:

• if you have diabetes. NAVALPRO 400 mg/4 ml may affect the results of your urine tests.
• if you experience nausea, vomiting or sudden stomach pain, you should tell your doctor immediately as these may be signs of inflammation of the pancreas or liver damage. Other symptoms to be on the lookout for is sudden abnormal physical weakness or lack of energy, tiredness, no appetite, swelling of your feet or hands, drowsiness and if the whites of your eyes and skin turn yellow. Your doctor will need to do blood tests.
• if you experience any type of fit (epilepsy), confusion, forgetfulness, tremor or abnormal sleepiness.
• if you have had thoughts of harming or killing yourself. If at any time you have these thoughts, immediately contact your doctor.
• if you have a carnitine palmitoyltransferase type II deficiency.
• if you have kidney problems. Your doctor may give you a lower dose.
• if you have brain disease or a metabolic condition affecting your brain.
• if you have a ‘urea cycle disorder’ where too much ammonia builds up in the body.
• if you have an illness called “systemic lupus erythematosus (SLE)” - a disease of the immune system which affects skin, bones, joints and internal organs.
• if you have experienced weight gain.
• if you know that there is a genetic problem caused by a mitochondrial disorder in your family.
• if NAVALPRO INJECTION 400 mg/4 ml is administered to your child who is less than 3 years of age, and who is taking other anti-epileptic medicines at the same time or has other neurological or metabolic diseases and severe forms of epilepsy.
• NAVALPRO INJECTION 400 mg/4 ml should only be used in adult males who plan to father a child if alternative treatment options are not suitable.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before receiving NAVALPRO 400 mg/4 ml. NAVALPRO 400 mg/4 ml should not be stopped suddenly as your original symptoms may come back.

NAVALPRO 400 mg/4 ml is always given to you by a doctor or nurse. This is because it needs to be given as a slow injection or infusion into the vein. If you are not sure why you are being given NAVALPRO 400 mg/4 ml or have any questions about how much NAVALPRO 400 mg/4 ml is being given to you, speak to your doctor or nurse. Your doctor will stop giving you NAVALPRO 400 mg/4 ml and change you to tablets, granules, syrup or liquid as soon as possible. Your doctor will decide how much to give you depending on your condition. The amount of NAVALPRO 400 mg/4 ml given to you or your child will depend on you or your child’s age or body weight. If you have the impression that the effect of NAVALPRO 400 mg/4 ml is too strong or too weak, tell your doctor or pharmacist. You will not be expected to give yourself NAVALPRO 400 mg/4 ml. It will be given to you by a person who is qualified to do so.

If you receive more NAVALPRO 400 mg/4 ml than you should

Since a healthcare provider will administer this medicine, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage. An overdosage of NAVALPRO 400 mg/4 ml can lead to the following symptoms: feeling sick or being sick, pupils of the eye become smaller, dizziness, loss of consciousness, weak muscles and poor reflexes, breathing problems, headaches, fits (seizures), confusion, memory loss and unusual or inappropriate behaviour.

If you missed a dose of NAVALPRO 400 mg/4 ml

Since a healthcare provider will administer NAVALPRO 400 mg/4 ml, it is unlikely that the dose will be missed.

NAVALPRO 400 mg/4 ml can have side effects. Not all side effects reported for NAVALPRO 400 mg/4 ml are included in this leaflet. Should your general health worsen or if you experience any untoward effects while being administered NAVALPRO 400 mg/4 ml, please consult your doctor, pharmacist or other healthcare provider for advice. If any of the following happens, stop receiving NAVALPRO 400 mg/4 ml and tell your doctor immediately or go to the casualty department at your nearest hospital:

• You have an allergic reaction. The signs may include: a rash, 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 fever, lymph node enlargement and possible impairment of other organs. This type of reaction to medicine is also called drug reaction with eosinophilia and systemic symptoms (DRESS).
• 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’. These are all very serious side effects. If you have them, you may have had a serious allergic reaction to NAVALPRO 400 mg/4 ml. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• liver problems and problems of the pancreas may show as a sudden illness which may happen in the first six months of treatment. It includes feeling and being sick, being very tired, sleepy and weak, 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.
• 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).
• poorly formed blood cells or blood cells that do not function normally (myelodysplastic syndrome). Symptoms are unusual tiredness, shortness of breath and unusual paleness. These symptoms may also be caused due to a low red blood cell count (anaemia).
• painful or swollen joints and muscle pain, unexplained fever, red rashes, most commonly on the face, chest pain upon deep breathing, unusual loss of hair, pale or purple fingers or toes from cold or stress, sensitivity to the sun and swelling of your legs or around your eyes. These are all symptoms of Systemic Lupus Erythematosus.
• blood clotting problems (bleeding for longer than normal), bruising or bleeding.
• changes in behaviour or mood 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 phenobarbitone, are taken at the same time or if the NAVALPRO 400 mg/4 ml starting dose is high or has been suddenly increased.
• breathing difficulty and pain due to inflammation of the lungs (pleural effusion).
• changes in the amount of ammonia in the blood. Symptoms of this condition are being sick, problems with balance and co-ordination, feeling mentally and physically sluggish or less alert.
• feeling tired or confused with loss of consciousness (coma) sometimes accompanied by hallucinations or fits.
• rapid uncontrollable movement of the eyes (nystagmus).
• an increase in the number and severity of fits (convulsions).
• brain injury (encephalopathy).
• kidney problems, including kidney failure, inflammation of the spaces between the small tubes in the kidney, defective kidney function causing sugar, protein, phosphates and uric acid to be excreted in the urine, bedwetting or increased need to pass urine.
• deafness. These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• feeling sick, stomach ache or diarrhoea, especially when starting treatment, swelling of gums or sore mouth, thirst or excessive drinking.
• weight gain - as your appetite may be increased.
• nausea, vomiting, headache, confusion, loss of energy, drowsiness and fatigue, due to low sodium levels in your blood (hyponatraemia).
• seeing or hearing things that are not there (hallucinations), confusion, aggression, agitation, disturbance in attention or lack of concentration (These side effects are mainly seen in children).
• feeling shaky (tremor), sleepy or unsteady when walking, loss of memory, dizziness, headache.
• hair loss which is usually temporary. When it grows back it may be more curly than before.
• nail and nail bed disorders.
• painful menstrual cramps during menstruation (dysmenorrhea).

Less frequent side effects:

• hearing loss.
• acne.
• increased levels of some hormones (androgens), which may lead to increased hair growth in women, including on the face, breasts or chest, acne or thinning hair.
• skin rash caused by narrow or blocked blood vessels (vasculitis).
• changes in women's periods (irregular periods or no period), hormonal disorder where the ovaries may develop small collections of fluid (follicles) and fail to release eggs (polycystic ovaries), impairment of ovarian function and of fertility in females.
• breast enlargement in men, male infertility.
• swelling of the feet and legs (oedema).
• underactive thyroid gland, which may cause tiredness or weight gain (hypothyroidism).
• Syndrome of Inappropriate Secretion of ADH (SIADH). SIADH is a condition in which the body makes too much antidiuretic hormone (ADH). This hormone helps the kidneys control the amount of water your body loses through the urine. You may experience a buildup of fluid in your body.
• abnormal behaviour, restlessness/hyperactivity and learning disorders (These side effects are mainly seen in children).
• tiredness, jerky muscle movement (ataxia), tingling or numbness of the hands or feet (pins and needles sensation).
• hair disorders (changes in texture, colour or growth), abnormal sweating.
• bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures.
• muscle pain and weakness (rhabdomyolysis).
• lowering of normal body temperature (hypothermia).
• abnormal blood clotting factors.
• obesity.

Side effects with an unknown frequency:

• inflammation and pain at the site of injection.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to: SAHPRA: https://www.sahpra.org.za/health-products-vigilance/ Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088. By reporting side effects, you can help provide more information on the safety of NAVALPRO 400 mg/4 ml.

Store all medicines out of reach of children. Store at or below 25 °C. Protect from light. Keep the vial and ampoule in the outer carton, until required for use. The solutions must be used immediately after reconstitution, and other conditions of use are the responsibility of the user and should not be more than 24 hours in a fridge, unless controlled and validated aseptic conditions are applied. Do not store in a bathroom. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).