Warnings and precautions

Do not take Ultramol Soluble and tell your doctor or pharmacist if:

• You are allergic (hypersensitive) to the active substances or any of the other ingredients in your medicine (listed in Section 6).
  Signs of an allergic reaction include a rash and breathing problems. There can also be swelling of the legs, arms, face, throat or tongue.
• The person going to take the tablets is under 12 years of age. Ultramol Soluble must not be given to children under 12 years of age.
• You are under 18 years of age and have had your tonsils or adenoids removed due to obstructive sleep apnoea syndrome
• You know that you metabolise very rapidly codeine into morphine
• You are breastfeeding or planning to breastfeed.

Do not take Ultramol Soluble if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Ultramol Soluble.

Take special care and check with your doctor or pharmacist before taking Ultramol Soluble if:

• You have severe kidney or liver problems
• You have non-cirrhotic alcoholic liver disease
• You have suffered from alcoholism, drug abuse, or dependence
• You are taking a benzodiazepine (used for the treatment of anxiety or sleep disorders), e.g. diazepam, clobazam, lorazepam, chlordiazepoxide, oxazepam, temazepam, nitrazepam, loprazolam, lormetazepam or clonazepam.

Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance that produces pain relief. Some people have a variation of this enzyme and this can affect people in different ways. In some people, morphine is not produced or produced in very small quantities, and it will not provide enough pain relief. Other people are more likely to get serious side effects because a very high amount of morphine is produced. If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.

Children and adolescents

Use in children and adolescents after surgery

Ultramol should not be used for pain relief in children and adolescents after removal of their tonsils or adenoids due to Obstructive Sleep Apnoea Syndrome.

Use in children with breathing problems

Ultramol is not recommended in children with breathing problems, since the symptoms of morphine toxicity may be worse in these children.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking this medicine.

Other medicines and Ultramol Soluble

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Ultramol Soluble can affect the way some other medicines work. Also, some other medicines can affect the way Ultramol Soluble works.

While taking Ultramol Soluble you should not take any other medicines which contain paracetamol.

This includes some painkillers, cough and cold remedies. It also includes a wide range of other medicines available from your doctor and more widely in shops.

Do not take this medicine and tell your doctor or pharmacist if you are taking the following:

• Benzodiazepines – used for treating anxiety or sleep disorders
• Medicines used to thin the blood such as warfarin
• Metoclopramide or domperidone – used to stop you feeling sick (nausea) or being sick (vomiting)
• Colestyramine – for lowering blood cholesterol levels

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Ultramol Soluble.

Concomitant use of opioids and benzodiazepines increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life threatening. Because of this, you should only take these together if prescribed by your doctor. Please follow your doctor’s dosage recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

Ultramol Soluble with drink and alcohol

Drinking too much coffee, or other drinks containing caffeine, while taking these tablets, may make you tense and irritable.

Ask your doctor or pharmacist before taking codeine if you have:

• suffered from alcoholism, drug abuse, or dependence.

Pregnancy and breast-feeding

Talk to your doctor before taking these tablets if:

• You are pregnant, think you may be pregnant or plan to get pregnant
• You are planning to breastfeed
• Do not take codeine while you are breastfeeding. Codeine and morphine passes into breast milk.

Driving and using machines

Ultramol Soluble can affect your ability to drive as it may make you sleepy or dizzy.

• Do not drive whilst taking this medicine until you know how it affects you
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
  • The medicine has been prescribed to treat a medical or dental problem and
  • You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
  • It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive whilst taking this medicine.

Ultramol Soluble contains sodium and sorbitol

Sodium: This medicine contains 388 mg sodium (main component of cooking/table salt) in each effervescent tablet. This is equivalent to 19,4 % of the recommended maximum daily dietary intake of sodium for an adult.

Sorbitol: This medicine contains 50 mg sorbitol in each effervescent tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.