Panadol Woman*

Disclaimer

Before you take Panadol Woman Tablets:

a. Do not take Panadol Woman in case of:

• Hypersensitivity to any of the preparation’s ingredients.
  
• Hypersensitivity to Atropine.
  
• Gastrointestinal obstruction.
  
• Colonic distension.
  
• Urinary retention in patients with prostatic hyperplasia.
  
• Tachyarrhythmia and tachycardia.
  
• Severe hepatic failure (mainly in patients with alcoholic liver damage).
  
• Severe renal failure.
  
• Angle -closure glaucoma.
  
• Alcoholism.
  
• Anaemia or glucose-6-phosphate dehydrogenase deficiency (favism).
  
• Myasthenia (muscle weakening).

• The therapy should also be discontinued, and medical attention sought if symptoms are serious and if patients report any visual acuity disorders or pain caused by raised ocular pressure.
  
• Panadol Woman should be discontinued immediately, and immediate medical advice should be sought in case of persistent or acute abdominal pain or if patient develops other symptoms such as: fever, nausea, changes in bowel habits, abdominal discomfort, low blood pressure, or blood in stool.
  
• In the elderly (the medicine may cause CNS-related disorders, Oral dryness, and particularly in males, urine retention). If the symptoms are severe, administration should be discontinued.

b. Take Special care with Panadol Woman in case of:

• Patients with cardiac disorders (mitral valve stenosis, coronary artery disease and acute myocardial infarction).
  
• Patients with intestinal ulceration (may slow down the gastrointestinal motility and cause constipation).
  
• Patients with gastroesophageal reflux disease and other chronic upper gastrointestinal smooth muscle motility disorders or pyloric stenosis.
  

• Panadol Woman contains Paracetamol. Do not take other Paracetamol containing medications. The concomitant use with other products containing paracetamol may lead to an overdose.
  
• Paracetamol overdose can cause liver damage and hepatic failure, which may require a liver transplant or lead to death.
  
• Comorbid liver disease may increase the risk of liver damage due to paracetamol. Any patient diagnosed with hepatic and/or renal function disorder should consult a doctor before starting treatment with Panadol Woman.
  
• Cases of hepatic function disorder or liver failure have been observed in patients with reduced levels of glutathione, such as those with acute malnutrition, anorexia, low body mass index or regular alcohol abuse, or in patients with sepsis. In patients with low glutathione levels (e.g. in sepsis), the use of paracetamol may increase the risk of metabolic acidosis.
  
• Less than 5% of patients allergic to acetylsalicylic acid derivatives may also be allergic to paracetamol.
  
• Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to increased risk of high anion gap metabolic acidosis (HAGMA), particularly in patients with severe renal impairment, sepsis, malnutrition, and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as those using maximum daily doses of paracetamol. Close monitoring, including measurement of urinary 5-oxoproline, is recommended.
  
• This product contains Sorbitol at 15 mg per tablet. If the patient has previously been diagnosed with hereditary fructose intolerance, the patient should consult a doctor before taking Panadol Woman.
  
• This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially “sodium-free”.
  
• Do not drink alcohol while taking Panadol Woman.
  
• Keep out of the reach and sight of children.
  
• Do not exceed the recommended dose.
  

c. Taking other medicines:

• Paracetamol may potentiate the anticoagulant effect of coumarin and indandione anticoagulants. Long-term daily use of paracetamol with anticoagulants increases the risk of bleeding. Occasional use has no significant effect.
  
• Caffeine may increase the effect of paracetamol.
  
• The absorption of paracetamol from the alimentary tract may be accelerated by the use of metoclopramide and delayed by the use of scopolamine.
  
• Salicylamide may prolong the elimination half life of paracetamol.
  
• Rifampicin, anti-epileptics medicines, sleep-inducing drugs and alcohol used with paracetamol may cause hepatic damage.
  
• The combination of paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs) in patients with renal failure may worsen renal disease.
  
• Tricyclic antidepressants, MAO inhibitors, quinidine, amantadine, disopyramide and butyrophenone in combination with Panadol Woman may increase anticholinergic effects, cause agitation and high fever.
  
• Hyoscine butylbromide slows down the gastrointestinal motility and reduces secretions in the gastrointestinal tract, which may reduce the absorption and pharmacological effects of concomitantly administered oral medications.
  
• Dopamine receptor antagonists such as metoclopramide may reduce the effect of this medicine on the gastrointestinal tract.
  
• Hyoscine butylbromide may increase tachycardia caused by beta-adrenergic drugs.
  

Please inform your doctor or pharmacist if you are taking:

• flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (high anion gap metabolic acidosis) that must have urgent treatment, and which may occur particularly in case of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.
  

d. Pregnancy and breast feeding:

Ask your doctor for advice before taking Panadol Woman.

Pregnancy:

• Panadol Woman Tablets should not be administered to pregnant women without medical advice.
  
• Panadol Woman may be used in pregnant women only when the benefits of its use outweigh the potential risks for the foetus; in such cases the lowest effective dose and shortest course of treatment should be considered.
  

Breast feeding:

• Panadol Woman is not recommended for use during lactation unless the benefits of its use outweigh the potential risks for the child; in such cases the lowest effective dose and shortest course of treatment should be considered.
  

Fertility:

• There are insufficient data on the potential effects of this product on fertility.
  

e. Driving and using machines:

Patients should be advised not to drive or use machines while taking Panadol Woman.

Possible side effects:

The following convention has been utilized for the classification of the frequency of adverse reactions: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥ 1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). Adverse reactions are listed by MedDRA system order class. Within each system organ class, the adverse drug reactions are ranked by frequency.