Stilpane 150 mg/8 mg/320 mg/32 mg Tablets

STILPANE is indicated for short term use (no longer than 10 days) in mild to moderate pain and fever associated with anxiety or tension.

Do not take STILPANE:

• If you are hypersensitive (allergic) to meprobamate, codeine phosphate, paracetamol, caffeine anhydrous or to any of the other ingredients of STILPANE (see section 6).
• If you are hypersensitive to other opioid analgesics such as morphine, tramadol, oxycodone.
• If you are pregnant or breastfeeding (see Pregnancy, breastfeeding and fertility).
• If you have porphyria (a disorder relating to the pigment of blood), as symptoms may be aggravated.
• If you have severe liver, kidney or lung problems.
• If you have a history of convulsions (epilepsy), as STILPANE can induce convulsions.
• If you have any breathing problems or bronchitis, especially in the presence of cyanosis (condition where your skin or lips turn blue due to an insufficient level of oxygen in the blood) and excessive mucus and fluid secretion in the airways.
• If you have just had an operation on your bile tract.
• If you are an alcoholic.
• If you have had a recent head injury or if you have a condition in which the pressure in your skull is increased.
• If the patient is in a coma.
• During an asthma attack.
• If you have heart failure caused by chronic lung disease.
• If you are using monoamine oxidase inhibitors (usually used to treat depression) or within fourteen days of stopping such treatment (see Other medicines and STILPANE).
• If you are an ultra-rapid metaboliser of CYP2D6 (see Warnings and precautions).
• If you are a child under the age of 12 years.
• If you have any of the following conditions where inhibition of contractions of the digestive tract (peristalsis) should be avoided: where there is a risk of a condition where the movement of the bowel is impaired (paralytic ileus), where bloating and swelling in the belly area (abdominal distension) develops, or in acute diarrhoeal conditions such as acute ulcerative colitis or antibiotic associated colitis (e.g. pseudomembranous colitis) or diarrhoea caused by poisoning.
• If you are a paediatric patient (aged below 18 years) and you are undergoing a procedure to remove your tonsils or adenoids for obstructive sleep apnoea syndrome.

Do not share medicines prescribed for you with any other person. For short term use only. Do not take STILPANE for longer than 10 days. STILPANE should not be used in children under 12 years of age. The usual dose for adults and children over 12 years is: Take two tablets orally three or four times a day as required. DO NOT EXCEED THE RECOMMENDED DOSE. Your doctor will tell you how long your treatment with STILPANE will last. If you are an elderly or debilitated (weak) patient, your healthcare provider may decide to reduce your dose. Always take STILPANE exactly as your doctor or pharmacist has instructed you. You should check with your doctor or pharmacist if you are unsure. If you have the impression that the effect of STILPANE is too strong or too weak, talk to your doctor or pharmacist.

If you take more STILPANE than you should

In the event of overdosage, consult a doctor or pharmacist immediately. If neither is available, seek help at the nearest hospital or poison centre. Prompt treatment is essential. Evidence of liver damage is often delayed until after the time for effective treatment has lapsed. Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, loss of appetite (anorexia) and possibly abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormal heartbeat has been reported. Overdosage with STILPANE can cause severe and/or fatal low blood pressure, respiratory depression, shock, heart failure and death. Extremely high doses and increased sensitivity to STILPANE may lead to agitation, increased urine, repeated vomiting with extreme thirst, disorientation (confusion), hallucinations, very high body temperature (41 °C or above), abnormal heartbeat including increased heart rate, electrolyte disturbances, convulsions and death.

If you forget to take STILPANE

Do not take a double dose to make up for forgotten individual doses. If you stop taking STILPANE STILPANE should not be used for longer than 10 days. If you are taking more STILPANE for longer periods of time, you could develop tolerance, addiction or an increased sensitivity to pain (hyperalgesia). In this case, the dose should be reduced gradually to prevent the occurrence of withdrawal symptoms. Withdrawal syndrome is characterised by some or all of the following: restlessness, watery eyes, runny nose, yawning, sweating, chills, muscle pain, pupils (of the eye) that are larger than usual and pounding or fluttering heart beat. Other symptoms may also develop including irritability, agitation, anxiety, excessive movement of a part of the body, tremor, weakness, sleeplessness, loss of appetite, stomach cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased breathing rate or heart rate.

If you notice any of these symptoms when you stop taking STILPANE, please contact your doctor.

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

• Sensitivity reactions: medicine fever and abscesses/ulcers, allergic skin condition, itching of the nose and medicine sensitivity, bleeding, skin rash,
• swelling of the hands, feet, ankles, face, eyes, lips and mouth, tongue 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 severe cutaneous adverse reactions (SCARs) such as Toxic Epidermal Necrolysis (TEN), Stevens - Johnson syndrome (SJS), acute generalised exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS)/Drug - induced hypersensitivity syndrome (DIHS), fixed drug eruption (FDE), allergic reactions, skin and mucous membrane rash (erythema multiforme).

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

• Seeing and hearing things that are not real (hallucinations),
• convulsions and uncontrolled muscle movements,
• deepening coma,
• raised skull pressure, that can present with symptoms such as severe headache, blurred vision and vomiting,
• reduced body temperature (hypothermia),
• decreased, irregular or increased heartbeat, or other changes in the way your heart beats (bradycardia, tachycardia, cardiac dysrhythmias, extrasystoles, palpitations),
• decreased white blood cells (neutropenia, leukopenia, agranulocytosis) that can present with symptoms such as fever, chills, sore throat, fatigue, which may be signs of an infection,
• too few blood cells of all types (pancytopenia), which can cause weakness, bruising or make infections more likely,
• increased number of a certain type of white blood cell (eosinophilia), that can present with symptoms such as weight loss, fevers, night sweats, cough, chest pain, rash,
• serious reduction of blood cells (due to failure of the bone marrow) that can cause weakness, bruising or make infections more likely (aplastic anaemia),
• decreased number of red blood cells which can make the skin pale and cause weakness or breathlessness (anaemia),
• increased blood pressure (hypertension),
• constriction of air passages which causes difficulty breathing, coughing, wheezing and chest tightness (bronchospasm, dyspnoea and large doses may produce respiratory depression),
• decreased blood platelets (thrombocytopenia), that can present with symptoms such as unusual or unexplained bruising or bleeding,
• internal bleeding of the stomach or intestines and gastric ulceration, that can present with symptoms such as black tarry stools, vomiting of blood, upper stomach pain, indigestion,
• inflammation of the pancreas (pancreatitis), that can present with symptoms such as upper stomach pain, stomach pain that radiates to the back, tenderness when touching the stomach,
• yellowing of skin or the whites of your eyes as this could be signs of problems with your liver (hepatic dysfunction),
• hearing loss,
• the need to use higher doses to get the same effect (dependence),
• inability to completely empty the bladder (urinary retention), complete absence of urine (anuria) or fatigue, changes in urination or swelling of the feet or ankles (kidney failure),
• the inability to achieve or maintain an erection (erectile dysfunction),
• tingling or pricking sensation (paraesthesia),
• reddish-purple patches on the skin (purpura).

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:
• Drowsiness, insomnia, sleep disturbances, headache, dizziness, balance disorder, a sensation that the environment is spinning (vertigo),
• anxiety, restlessness, tolerance,
• constipation, nausea, vomiting, abdominal pain,
• general feeling of being unwell (malaise).

Less frequent side effects:

• Difficulty in urination (micturition) or painful urination (dysuria), severe pain in the side or back, sometimes radiating to the groin caused by spasms in of the ureter muscles (uretic spasm), difficulty in complete or partial emptying of the bladder (urinary retention),
• muscle rigidity,
• sweating,
• light headedness when standing up (orthostatic hypotension),
• facial flushing,
• confusion, mood changes,
• pupil (eye) contraction (miosis),
• sleepiness (sedation), faintness,
• excitement, cheerfulness (euphoria), feeling unhappy or uneasy (dysphoria),
• weakness,
• dry mouth,
• diarrhoea,
• disturbance of vision,
• raised liver enzyme levels, sharp pain in the upper abdomen often triggered by eating fatty foods (biliary spasm),
• haemoglobin decreased in blood tests.

Side effects with an unknown frequency:

• Low blood pressure (hypotension),
• spasm of the bile duct (may be associated with altered liver enzyme values),
• dark urine, yellowing of the skin (increased transaminases),
• ringing in the ears (tinnitus),
• stomach cramps, increased stomach secretions, stomach ulcers,
• tremor,
• tiredness,
• high blood sugar levels (hyperglycaemia),
• lack/loss of appetite (anorexia),
• sexual dysfunction, decreased potency, decreased libido,
• fever, splenomegaly and lymphadenopathy,
• mental depression, nightmares,
• visual aura that may precede a migraine headache (scintillating scotoma),
• blurred or double vision or other changes in vision,
• headache, nausea, vomiting, dizziness, feeling weak or tired, loss of appetite and increased heartbeat due to high acidity in the body (pyroglutamic aciduria (5-oxoprolinuria) and high-anion gap metabolic acidosis),
• cough suppression,
• itchy, inflamed rash caused by skin contact with an irritant (contact dermatitis),
• reaction to a medicine that is not expected (idiosyncrasy),
• itching of the nose,
• reduction in the amount of urine (antidiuretic effect).

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: via the 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/ +27 (0)11 239 - 6200. By reporting side effects, you can help provide more information on the safety of STILPANE.

Store all medicines out of reach of children. Store at or below 25 °C, in a well-closed container. Protect from light. Keep in original packaging until required for use. 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).