Navalpro CR

NAVALPRO CR belongs to a group of medicines called anticonvulsants and antiepileptics. It is used to treat epilepsy (fits) and manic episodes in bipolar disorder (disorder that causes extreme mood swings that includes emotional highs and lows) in adults.

Do not take NAVALPRO CR:

• if you are hypersensitive (allergic) to sodium valproate or any of the other ingredients of NAVALPRO CR (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 bipolar disorder.
• if you are pregnant for the treatment of epilepsy, unless there is no suitable alternative treatment (see section titled Pregnancy, breastfeeding and fertility).
• if you are able to have a baby, unless you use an effective method of birth control (contraception) at all times during your treatment with NAVALPRO CR and the conditions of the Pregnancy Prevention Programme are met. Do not stop taking NAVALPRO CR or your birth control (contraception) until you have discussed this with your doctor. Your doctor will advise you further (see section titled Pregnancy, breastfeeding and fertility).
• if you have liver problems, or you or your family have a history of liver problems, including the following:
• if you have short- or long-term (severe) hepatitis (inflammation of the liver).
• If you (or any of your close relatives) have a past history of severe hepatitis (inflammation of the liver), especially when caused by medicines.
• if you have porphyria (rare hereditary illness that may affect the skin or nervous system).
• if you have a genetic problem caused by a mitochondrial disorder (e.g. Alpers-Huttenlocher syndrome).
• if you have a metabolic disorder such as “urea cycle disorder” where too much ammonia builds up in the body.
• if you have an inborn deficiency in carnitine (a very rare metabolic disease) that is untreated.
• if you are taking medicines called monoamine oxidase inhibitors (such as selegiline, phenelzine) – see section titled Other medicines and NAVALPRO CR.

Do not share medicines prescribed for you with any other person. Always take NAVALPRO CR exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are unsure. It is important to take NAVALPRO CR every day. The tablets should be swallowed whole with a little water and must not be crushed.

Take NAVALPRO CR once or twice daily with food. “Controlled release” means that the active ingredient, sodium valproate, is slowly released from the tablets over a period of time.

For the treatment of epilepsy

Adults: The starting dose is 600 mg daily. Your doctor will gradually increase this dose by 200 mg every 3 days, depending on your condition and how you respond to treatment.

For the acute and maintenance treatment of manic episodes associated with bipolar disorder

Adults: The starting dose is 1 000 mg daily. Your doctor will increase the dose as rapidly as possible depending on how you respond to treatment.

Your doctor will tell you how long your treatment with NAVALPRO CR will last. Do not stop taking your medicine without discussing it with your doctor. If you have the impression that the effect of NAVALPRO CR is too strong or too weak, you should talk to your doctor or pharmacist.

If you take more NAVALPRO CR than you should

You may experience an increase in side effects and their frequency. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Take this leaflet and any remaining tablets with you, so that the doctor knows what you have taken.

If you forget to take NAVALPRO CR

Do not take a double dose to make up for a forgotten dose. If you miss a dose of NAVALPRO CR, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule.

NAVALPRO CR can have side effects. Not all side effects reported for NAVALPRO CR are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking NAVALPRO CR, please consult your doctor, pharmacist or other healthcare provider for advice.

If any of the following happens, stop taking NAVALPRO CR 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 breathing and swallowing,
• 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), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS). These are all very serious side effects. If you have them, you may have had a serious reaction to NAVALPRO CR. 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),
• 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 (petechia), bruising or prolonged bleeding after injury. Blood disorders (such as thrombocytopenia, anaemia, leucopoenia, 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),
• changes in the amount of ammonia in the blood (symptoms are mental confusion, tiredness, and possibly coma or death, vomiting, problems with balance, feeling less alert),
• 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),
• 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),
• 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),
• liver problems (being nauseous and vomiting many times, being very tired, sleepy and weak, stomach pain, yellowing of the skin or whites of the eye (jaundice)),
• inflammation of the pancreas (acute abdominal pain); nausea and vomiting; see section titled Take special care with NAVALPRO CR,
• 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,
• 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:
• Heartburn or indigestion,
• low blood levels of sodium which can cause tiredness and muscle twitching, (hyponatraemia),
• increased weight,
• sleep disorders, inability to sleep, nervousness, changing moods, aggression,
• inability to pay attention,
• headache, shaking or quivering, trembling of hands and arms (tremor), sleepiness (somnolence), memory problems, clumsiness or unsteadiness, involuntary, rapid movement of one or both eyes (nystagmus),
• blurred vision in one eye (amblyopia),
• flu, sore throat (pharyngitis),
• ringing in ears; deafness,
• nausea and vomiting, abdominal or stomach pain, loose stools (diarrhoea), overgrowth of gum tissue (gingival hyperplasia),
• swelling in the mouth (stomatitis),
• hair loss or thinning of hair, nail and nail bed disorders,
• back pain,
• inability to control the flow of urine (urinary incontinence),
• painful menstrual periods (dysmenorrhea) change in menstrual periods, weight gain or facial hair (polycystic ovaries),

Less frequent side effects:

• High level of sugar in your blood (hyperglycaemia), increased levels of some hormones (androgens), which may lead to acne, thinning hair or increased hair growth on breasts or chest (hyperandrogenism), underactive thyroid gland which can cause tiredness or weight gain (hypothyroidism) or weight loss,
• seeing or hearing things that are not really there (hallucinations), feeling extremely restless or irritated (agitation), abnormal dreams, anxiety, feeling sad, irritability,
• obesity, fatigue,
• reversible tremor, stiffness and shuffling (parkinsonism),
• becoming unreactive, problems with speech, painful and stiff muscles (hypertonia), repetitive, involuntary movements, such as grimacing and eye blinking (tardive dyskinesia),
• abnormal behaviour, loss of muscle control (psychomotor hyperactivity), learning disorder,
• tingling sensation under the skin (paraesthesia), increase in alertness, hyperactivity, disturbances in behaviour,
• seeing double (diplopia), rolling of the eyes, dry eyes, spots before the eyes, eye infection, eye pain,
• ear infection (otitis media); ear pain,
• changes in the speed that your heart beats (tachycardia), feeling your heartbeat harder (palpitations),
• light-headedness, general weakness, fainting (hypotension),
• increased cough, runny nose, difficulty breathing, bleeding from the nose,
• dry mouth, constipation, changes in appetite, dental pain; difficulty controlling stool movement (faecal incontinence),
• swelling of the tongue (glossitis), wind in the stomach, bloated full feeling, diarrhoea, cramps, nausea, vomiting and fever (gastroenteritis),
• changes in sense of taste,
• red tender lumps involving hair follicles (furunculosis),
• abnormal hair texture, hair colour changes, abnormal hair growth,
• dark reddish urine, a decreased amount of urine, weakness and muscle pains or stiffness (rhabdomyolysis),
• abnormality in kidney tubes (Fanconi’s syndrome), bed wetting (enuresis),
• ear infection; ear pain,
• brittle bones and fractures,
• absence of menstrual period (amenorrhoea), swelling of the vagina (vaginitis), swollen breasts (gynecomastia),
• swelling of hands and feet due to retained fluid (peripheral oedema),
• abnormally low body temperature (hypothermia),
• fertility problems in both men and women.

Side effects with an unknown frequency:

• Change in levels of liver enzymes, salts or sugars shown up on blood and urine tests,
• various birth defects and developmental delays have been reported in babies born of women taking NAVALPRO CR during pregnancy (see section titled Pregnancy, breastfeeding and fertility for details and advice).

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 Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. 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 CR.

Store all medicines out of reach of children. Store at or below 25 °C. Keep the blisters in the carton in order to protect from light and moisture. 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).