Navalpro Liquid 200 mg/5 ml

NAVALPRO LIQUID belongs to a group of medicines called anticonvulsants or anti-epileptics. It is used to treat epilepsy (fits) in adults and children.

Do not take/give NAVALPRO LIQUID:

• if you or your child are hypersensitive (allergic) to sodium valproate or any of the other ingredients of NAVALPRO LIQUID (listed in section 6),
• 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 child are a female able to have a baby, you must not take NAVALPRO LIQUID unless you use an effective method of birth control (contraception) at all times during your treatment with NAVALPRO LIQUID and the conditions of the pregnancy prevention programme are met. Do not stop taking NAVALPRO LIQUID or your contraception until you have discussed this with your doctor. Your doctor will advise you further (see section Pregnancy, breastfeeding and fertility),
• if you or your child have liver problems, or you or your family have a history of liver problems,
• if you or your child have a known metabolic disorder (urea cycle disorder),
• if you or your child have a rare illness called porphyria,
• if you have a genetic problem caused by a mitochondrial disorder (e.g. Alpers-Huttenlocher syndrome),
• if your child is under 2 years of age and may have a genetic problem caused by a mitochondrial disorder (e.g. Alpers-Huttenlocher syndrome).

Warnings and precautions

Take special care with NAVALPRO LIQUID: NAVALPRO LIQUID contains sodium valproate which can seriously harm an unborn baby when taken during pregnancy. If you are a female able to have a baby you should use an effective method of birth control (contraception) without interruption during your entire treatment with NAVALPRO LIQUID. Your doctor will discuss this with you, but you must also follow the advice in section 2 of this leaflet. Schedule an urgent appointment with your doctor if you want to become pregnant or if you think you are pregnant. Do not stop taking NAVALPRO LIQUID unless your doctor tells you to as your condition may become worse. If you are a parent or caregiver of a female child treated with NAVALPRO LIQUID, you must also read section 2 of this leaflet carefully and contact your child’s doctor once the child experiences her first period (see section Pregnancy, breastfeeding and fertility).

Do not share medicines prescribed for you with any other person. Always take/give NAVALPRO LIQUID exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will calculate your/your child’s dose according to age and body weight. NAVALPRO LIQUID should preferably be taken with or after food. NAVALPRO LIQUID should not be mixed with water or any other liquid. NAVALPRO LIQUID should be given in divided doses e.g. doses should be taken/given 2 or 3 times a day. Your doctor will tell you how long your treatment with NAVALPRO LIQUID will last. If you have the impression that the effect of NAVALPRO LIQUID is too strong or too weak, tell your doctor or pharmacist.

If you take more NAVALPRO LIQUID than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take/give NAVALPRO LIQUID

Do not take/give your child a double dose to make up for forgotten individual doses. If you or your child have missed a dose of NAVALPRO LIQUID, take/give your child the dose that has been missed as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. If you have forgotten to take/give your child several doses, contact your doctor without delay.

If you stop taking NAVALPRO LIQUID

NAVALPRO LIQUID should be stopped in a gradual manner under the supervision of a doctor.

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

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting,
• blistering of the skin, mouth, eyes and genitals as these may be due to a serious allergic reaction known as Stevens-Johnson Syndrome (SJS),
• 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 called ‘erythema multiforme.’

These are all very serious side effects. If you have them, you may have had a serious reaction to NAVALPRO LIQUID. 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:

• shortness of breath, fatigue, easy bruising or paleness. This may be a sign of the bone marrow failing, or a type of cancer in which the blood-forming cells in the bone marrow become abnormal. This leads to low numbers of one or more types of blood cells (myelodysplastic syndromes (MDS)),
• blood disorders which are usually detected in blood tests, but may be seen as pale skin, tiredness, fever, sore throat and mouth, small red spots on the skin, bruising or prolonged bleeding after injury. Blood disorders (such as thrombocytopenia, anaemia, leucopenia, pancytopenia) may be seen with symptoms of severe chills, mouth ulcers, headache, shortness of breath and dizziness,
• nausea, vomiting, headache, confusion, weakness or fatigue. These may be signs of a condition in which there are high levels of a hormone which causes the body to retain water (Syndrome of Inappropriate Secretion of ADH (SIADH)),
• too much ammonia in your body (hyperammonaemia) which can cause problems like confusion, tiredness, and possibly coma or death. A child's reaction to too much ammonia can include seizures, breathing trouble, lower response, and potentially death,
• thoughts of harming or killing yourself (suicidal ideation),
• memory loss, personality changes, fits (seizures), loss of consciousness (coma). These may be signs of brain damage (encephalopathy),
• worsened memory, thinking, behaviour and the ability to perform everyday activities (dementia, brain deterioration),
• uncontrollable muscle movements, abnormal muscle twitches or restlessness which may be signs of an extrapyramidal disorder,
• fever, tiredness, weight loss, muscle and joint pain, tingling under the skin. These may be signs of swelling of blood vessels (vasculitis), which causes changes in the blood vessel walls, including thickening, weakening, narrowing or scarring,
• uncontrollable bleeding from any part of your body (haemorrhage),
• coughing, sharp chest pain or shortness of breath. These may be signs of fluid building up in the lungs (pleural effusion),
• severe upper stomach pain, nausea, vomiting. This may be a sign of swelling of the pancreas (pancreatitis). Young children are at risk of pancreatitis,
• yellowing of the skin or eyes (jaundice), extreme tiredness (asthenia), loss of appetite (anorexia), lack of energy (lethargy), sleepiness (drowsiness), vomiting or abdominal pain. These may be signs of liver damage or liver failure (hepatic failure),
• tiredness, joint pain, rash, fever, muscle pain. These may be signs of a disease of the immune system which affects skin, bones, joints and internal organs, called systemic lupus erythematosus (SLE),
• dark, reddish urine, a decreased amount of urine, weakness, muscle aches. These may be signs of an abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis),
• a reduced amount of urine, swelling of your legs, ankles and feet, shortness of breath, extreme tiredness, nausea, chest pain. These may be signs of kidney failure,
• inability of a male to father a child (male infertility),
• bruising or bleeding which takes a long time to stop. These may be signs of blood clotting problems, such as blood not clotting very well (coagulation factors decreased).

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:
• Low blood levels of sodium which can cause tiredness and confusion, muscle twitching, fits and coma (hyponatraemia),
• increased weight,
• confusional state, seeing or hearing things that are not really there (hallucinations), feeling extreme anger which may lead to violence (aggression),
• feeling extremely restless or irritated (agitation), inability to pay attention (mostly seen in children),
• shaking or quivering (tremor), sleepiness (somnolence), loss of memory, headache, involuntary, rapid movement of one or both eyes (nystagmus),
• nausea, stomach pain (gastralgia), loose stools (diarrhoea), vomiting, overgrowth of gum tissue (gingival hyperplasia) (mostly seen in children),
• swelling in the mouth (stomatitis),
• hair loss,
• nail and nail bed disorders,
• inability to control the flow of urine (urinary incontinence),
• painful menstrual periods (dysmenorrhoea), hormonal disorder causing acne, irregular menstrual cycle, weight gain or facial hair (polycystic ovaries), swelling of breast tissue in males (gynecomastia).

Less frequent side effects:

• Increased levels of some hormones (androgens), which may lead to acne, thinning hair or increased hair growth on the face, breasts or chest (hyperandrogenism),
• underactive thyroid gland which can cause tiredness or weight gain (hypothyroidism),
• obesity,
• abnormal behaviour, restlessness (psychomotor hyperactivity), learning disorder (mostly seen in children),
• confusion, a state of near-unconsciousness or insensibility (stupor), abnormal lack of energy (lethargy),
• fits (convulsions), reversible tremor, stiffness and shuffling (parkinsonism),
• difficulty in controlling movements (ataxia), tingling sensation under the skin (paraesthesia), increase in alertness, hyperactivity, disturbances in behaviour,
• seeing double (diplopia),
• hearing loss,
• abnormal hair texture, hair colour changes, abnormal hair growth,
• weakening of bones (osteopenia), thinning of bones (osteoporosis), breaks in bones (fractures),
• absence of menstrual period (amenorrhoea), irregular periods, impairment of ovarian function and of fertility in females,
• swelling of hands and feet due to retained fluid (peripheral oedema),
• abnormally low body temperature (hypothermia).

Side effects with an unknown frequency:

• Bed-wetting (enuresis) (mostly seen in children).

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 LIQUID.

Store all medicines out of reach of children. Store at or below 30 °C.

• 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).