Actimorph 20 mg Orodispersible tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Actimorph Orodispersible tablets are and what they are used for
2. What you need to know before you take Actimorph Orodispersible tablets
3. How to take Actimorph Orodispersible tablets
4. Possible side effects
5. How to store Actimorph Orodispersible tablets
6. Contents of the pack and other information

Do not take Actimorph Orodispersible tablets

• if you are allergic to morphine or any of the other ingredients of this medicine (listed in section 6);
• if the patient is a child under 6 months of age (see section "Children");
• if you have breathing problems, such as obstructive airways disease or respiratory depression. Your doctor will have told you if you have these conditions. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected;
• if you have severe bronchial asthma;
• if you have a head injury that causes a severe headache or makes you feel sick. This is because this medicine may make these symptoms worse or hide the extent of the head injury;
• if you have uncontrolled epilepsy;
• if you have recent onset liver disease;
• if you have a disease where the small bowel (part of your gut) does not function properly (paralytic ileus), your stomach empties more slowly than it should (delayed gastric emptying) or you have sudden acute pain in your abdomen;
• if you are taking medicines containing buprenorphine, nalbuphine and pentazocine (substances which have properties similar to those of morphine and which may reduce the effects of morphine) as well as medicines containing naltrexone, nalmefene and sodium oxybate;
• if you are taking a type of medicine known as monoamine oxidase inhibitors, used as antidepressants (such as tranylcypromine, phenelzine, isocarboxazid, moclobemide, and linezolid), or if you have taken these medicines in the last two weeks.

Warnings and precautions

Talk to your doctor or pharmacist before taking Actimorph Orodispersible tablets, especially:

• if you are dependent on opioids, or if you have a history of substance abuse;
• if you have breathing problems, such as impaired lung function or decreased respiratory capacity. Symptoms may include breathlessness and coughing;
• if you have a severe heart problem after a long-term lung disease (cor pulmonale);
• if you have a severe headache or are feeling dizzy, as it may indicate that the pressure in your skull is increased;
• if you have disturbances of consciousness;
• if you have low blood pressure (hypotension, associated with low circulating blood volume (hypovolaemia);
• if you have prostate problems;
• if you have urinary tract constriction or colic of the urinary tract;
• if you have problems with your gallbladder;
• if you have a bowel obstruction or an inflammatory bowel disorder;
• if you have a tumour of the adrenal gland;
• if you have experienced weakness, fatigue, lack of appetite, nausea, vomiting or low blood pressure. This may be symptoms of low production of the hormone cortisol in the adrenal glands, and you may need to take a hormone supplement;
• if you have inflammation of the pancreas (which can cause severe pain in the abdomen and back);
• if you have an under-active thyroid gland (hypothyroidism), kidney or long-term liver problems, as you may need a lower dose;
• if you suffer from, or have ever suffered from epilepsy, seizures (fits);
• if you have a sickle cell disease and you take morphine, your doctor will closely monitor you due to a possible association with acute chest syndrome. Your doctor will closely monitor you in case of association with morphine.

Use of Actimorph Orodispersible tablets may lead to the development of tolerance requiring higher doses to achieve the desired analgesic effect. Chronic use of Actimorph Orodispersible tablets may lead to physical dependence and withdrawal syndrome may occur if the therapy is stopped abruptly. When therapy with morphine is no longer necessary, it may be advisable to gradually reduce the daily dose to avoid the occurrence of withdrawal syndrome symptoms. The most common withdrawal symptoms are listed in section 3. If they occur in your case, your doctor may change the type of medicine or change the duration between doses.

The active substance morphine has a potential for abuse similar to other strong opioids (strong painkillers). The development of a psychological dependence is possible. In this case, for example, you may have started to think a lot about when you can take the next dose, even if you do not need it to relieve your symptoms. If you have once been dependent on drugs or alcohol, Actimorph Orodispersible tablets should be used with special caution.

Actimorph Orodispersible tablets should be used with caution before and after surgery (increased risk of intestinal paralysis or respiratory depression).

Talk to your doctor or pharmacist if you experience any of the following symptoms while taking Actimorph Orodispersible tablets:

• Increased sensitivity to pain despite the fact that you are taking increasing doses (hyperalgesia). Your doctor will decide whether you will need a change in dose or a change in strong analgesic ("painkiller"), (see section 2);
• Weakness, fatigue, lack of appetite, nausea, vomiting or low blood pressure. This may be a symptom of the adrenals producing too little of the hormone cortisol, and you may need to take hormone supplement;
• Loss of libido, impotence, cessation of menstruation. This may be because of decreased sex hormone production;
• The most significant risk of opioid overdose is a flattening and slowing of breathing (respiratory depression);
• Constipation is common under a morphine treatment. Especially if you had problems with bowel movements before you started taking it, talk to your doctor.

Sleep-related breathing disorders

Actimorph Orodispersible tablets can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.

You must only take the tablets by mouth. These tablets should never be dispersed and injected as this may lead to serious side effects, which may be fatal.

Elderly people

This medicine should be used with caution in the elderly (see section "How to take Actimorph Orodispersible tablets").

Children

Do not give this medicine to children under 6 months of age (see section "Do not take Actimorph Orodispersible tablets").

Other medicines and Actimorph Orodispersible tablets

Tell your doctor if you are taking, have recently taken or might take any other medicines.

This is especially important if you are taking or might take any other medicines mentioned below:

• rifampicin to treat e.g. tuberculosis. It may reduce the effect of morphine;
• concomitant use of Actimorph Orodispersible tablets and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However if your doctor does prescribe Actimorph Orodispersible tablets together with sedative medicines, the dose and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose 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;
• medicines which have a central, i.e. dampening effect on brain function or alcohol, it may increase the side effects of morphine;
• medicines to help you to sleep or stay calm (for example benzodiazepines, tranquillizers, hypnotics or sedatives);
• general anaesthetics;
• medicines to treat psychiatric disorders (such as phenothiazines);
• medicines to treat depression;
• muscle relaxants as morphine can increase the effect;
• medicines to treat high blood pressure;
• gabapentin to treat epilepsy or neuropathic pain (pain due to nerve problems);
• buprenorphine, nalbuphine or pentazocine, as well as naltrexone, nalmefene and sodium oxybate. Do not combine Actimorph Orodispersible tablets with these medicines. If you have any doubt, please talk to your doctor;
• other strong painkillers;
• medicines to treat depression, called monoamine oxidase inhibitors (MAOIs), or within two weeks of stopping their use (see section 2, "Do not take Actimorph Orodispersible tablets");
• medicines used to prevent or relieve the symptoms of an allergy (antihistamines);
• medicines to treat Parkinson’s disease;
• certain types of medicines to stop you feeling or being sick;
• some medicines used to treat blood clots (e.g. clopidogrel, prasugrel, ticagrelor) may have delayed and decreased effect when taken together with morphine;
• ritonavir to treat HIV;
• cimetidine to treat stomach ulcers, indigestion or heartburn.

Actimorph Orodispersible tablets with alcohol

Do not drink alcohol or take any medicines containing alcohol during treatment with this medicine.

Drinking alcohol during your treatment with this medicine may make you more drowsy or increase the risk of serious sides effects such as shallow breathing with the risk of stopping breathing and loss of consciousness.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

This medicine should not be used as much as possible in patients who are pregnant or nursing mothers, unless your doctor deems it absolutely necessary and considers the benefit for you to be significantly greater than the risk for the child.

Men and women of child-producing/child bearing potential must use reliable contraception while using Actimorph Orodispersible tablets.

If Actimorph Orodispersible tablets are used for a long time during pregnancy, there is a risk of the new-born child having withdrawal (abstinence) symptoms which should be treated by a doctor.

Withdrawal (abstinence) symptoms in babies born to mothers may include high-pitched crying, irritability and restlessness, shaking (tremor), feeding difficulties and sweating.

Breast-feeding

You should not breast-feed during your treatment with this medicine as morphine is known to pass into breast milk.

Driving and using machines

Actimorph Orodispersible tablets may cause a number of side effects such as drowsiness which could affect your ability to drive or use machines (see section 4 for a full list of side effects). These are usually most noticeable when you first start taking this medicine, or when changing to a higher dose. If you are affected, you should not drive or use machinery.

Actimorph Orodispersible tablets contains benzyl alcohol, sodium and sulphites

Actimorph 1 mg Orodispersible tablets: This medicine contains 0.1 microgram benzyl alcohol in each orodispersible tablet.

Actimorph 2.5 mg Orodispersible tablets: This medicine contains 0.25 microgram benzyl alcohol in each orodispersible.

Actimorph 5 mg Orodispersible tablets: This medicine contains 0.5 microgram benzyl alcohol in each orodispersible tablet.

Actimorph 10 mg Orodispersible tablets: This medicine contains 0.6 microgram benzyl alcohol in each orodispersible tablet.

Actimorph 20 mg Orodispersible tablets: This medicine contains 0.8 microgram benzyl alcohol in each orodispersible tablet.

Actimorph 30 mg Orodispersible tablets: This medicine contains 1 microgram benzyl alcohol in each orodispersible tablet.

Benzyl alcohol may cause allergic reactions.

Do not use for more than a week in young children (less than 3 years old), unless advised by your doctor or pharmacist.

Ask your doctor or pharmacist for advice if you are pregnant or breast feeding. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called "metabolic acidosis").

Ask your doctor or pharmacist for advice if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called "metabolic acidosis").

This medicine contains less than 1 mmol sodium (23 mg) per orodispersible tablet, that is to say essentially ‘sodium-free’. Sulphites may rarely cause severe hypersensitivity reactions and bronchospasm.

Use in adults and adolescents over 16 years

The usual starting dose is 10-20 mg every 4-6 hours. Your doctor will decide how many orodispersibles tablets you should take.

If you are still in pain while taking these tablets, talk to your doctor.

Do not exceed the dose recommended by your doctor. You should check with your doctor or pharmacist if you are not sure.

Use in elderly patients (over 65 years)

A reduction in dose is recommended in the elderly (dose reduction such as 2.5-5 mg every 4-6 hours).

Use in patients with liver or kidney problems

This medicine should be administered with particular care in patients with liver or kidney problems.

Patients with a suspected delay in the gastrointestinal passage

This medicine should be administered with particular care in patients with a suspected delay in the gastrointestinal passage.

Use in children and adolescents

Use in adolescents: 13 to 16 years (40-60 kg)

The usual starting dose is 5-20 mg every 4-6 hours.

Use in children: 6 to 12 years (18-40 kg)

The usual starting dose is 5-10 mg every 4-6 hours.

1 to 5 years (9-18 kg)

The usual starting dose is 2.5-5 mg every 4-6 hours.

over 6 months (6-9 kg)

The usual starting dose is 1 mg every 4-6 hours.

Method of administration

• Oral use.
• Place the orodispersible tablet in the mouth. It will melt rapidly and can then be swallowed.
• Alternatively, you may place the orodispersible tablet in a spoon with a small quantity of water before giving it to your child or to people who have difficulties to swallow. It will rapidly melt enough to be swallowed more easily. This method of administration should be used in children below the age of 6 years.

Opening instructions

This medicine is available in peelable, child resistant perforated unit dose blisters.

Do not push the tablet through the foil.

Pull off a single dose by tearing along the perforated line on the blister and peel back the foil on the blister to expose the orodipersible tablet.

Duration of treatment

Do not take this medicine for longer than absolutely necessary.

Any change or interruption of treatment should be made as recommended by your doctor (see section "If you stop taking Actimorph Orodispersible tablets").

If you take more Actimorph Orodispersible tablets than you should

Call your doctor or hospital straight away as you may need emergency treatment in a hospital. An overdose can have consequences and can be fatal.

When seeking medical attention make sure that you take this leaflet and any remaining orodispersible tablets with you to show to the doctor.

People who have taken an overdose may have narrow pupils, feel very sleepy, decrease in heart rate, low blood pressure, drop of body temperature, have or get pneumonia from inhaling vomit or foreign matter (symptoms may include breathlessness, cough and fever).

People who have taken an overdose may also have breathing difficulties leading to unconsciousness or even death.

In more serious cases, circulatory insufficiency may occur and eventually lead to a deep coma.

Muscle damage up to muscle decay can occur (possibly resulting in kidney failure).

Under no circumstances should you place yourself in situations that require increased attention, such as driving.

The following measures in case of overdose are recommended until a doctor arrives:

Keep awake, give breathing commands, breathing aid.

If you forget to take Actimorph Orodispersible tablets

If you have taken a lower dose of Actimorph Orodispersible tablets than intended or have completely forgotten to take it, this will result in insufficient or no pain relief.

Do not take a double dose to make up for a forgotten dose.

Do not take two doses within 4 hours.

Continue the use in the recommended manner.

If you stop taking Actimorph Orodispersible tablets

Do not stop treatment with Actimorph Orodispersible tablets unless agreed with your doctor.

If you want to stop treatment with Actimorph Orodispersible tablets, ask your doctor how to slowly decrease the dose to avoid abstinence (withdrawal) symptoms.

Withdrawal symptoms may include body aches, tremors, diarrhea, abdominal pain, nausea, flu-like symptoms, rapid heartbeat and large pupils. Psychological symptoms are a pronounced feeling of dissatisfaction, anxiety and irritability.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

What Actimorph Orodispersible tablets contain

• The active substance is morphine sulfate.
  Actimorph 1 mg Orodispersible tablets contain 1 mg of morphine sulfate.
  Actimorph 2.5 mg Orodispersible tablets contain 2.5 mg of morphine sulfate.
  Actimorph 5 mg Orodispersible tablets contain 5 mg of morphine sulfate.
  Actimorph 10 mg Orodispersible tablets contain 10 mg of morphine sulfate.
  Actimorph 20 mg Orodispersible tablets contain 20 mg of morphine sulfate.
  Actimorph 30 mg Orodispersible tablets contain 30 mg of morphine sulfate.
• The other ingredients are: mannitol, hydroxypropyl cellulose, microcrystalline cellulose, crospovidone type A, acesulfame potassium, orange flavour (including benzyl alcohol, sodium, sulphites), silicon dioxide, magnesium stearate.

What Actimorph Orodispersible tablets look like and contents of the pack

Actimorph 1 mg Orodispersible tablets are round, convex, 5 mm of diameter, white tablets engraved "1" on one side and smooth on the other side.

Actimorph 2.5 mg Orodispersible tablets are round, convex, 7 mm of diameter, white tablets engraved "2.5" on one side and smooth on the other side.

Actimorph 5 mg Orodispersible tablets are round, convex, 8.5 mm of diameter, white tablets engraved "5" on one side and smooth on the other side.

Actimorph 10 mg Orodispersible tablets are round, convex, 10 mm of diameter, white tablets engraved "10" on one side and smooth on the other side.

Actimorph 20 mg Orodispersible tablets are round, convex, 11 mm of diameter, white tablets engraved "20" on one side and smooth on the other side.

Actimorph 30 mg Orodispersible tablets are round, convex, 12 mm of diameter, white tablets engraved "30" on one side and smooth on the other side.

Actimorph Orodispersible tablets are available in packs of 56 orodispersible tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Manufacturer

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: