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The product code(s) for this leaflet is: PL 06934/0249.
Actimorph 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg Orodispersible tablets
Actimorph 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg Orodispersible tablets
morphine sulfate
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
The active substance of Actimorph Orodispersible tablets is morphine which belongs to a group of medicines called strong analgesics or ‘painkillers’ from the opioids group.
This medicine has been prescribed by your doctor to relieve severe pain which can be adequately managed only with opioids.
Tolerance, dependence, and addiction
This medicine contains morphine which is an opioid medicine. Repeated use of opioids can result in the drug being less effective (you become accustomed to it, known as tolerance). Repeated use of Actimorph can also lead to dependence, abuse, and addiction, which may result in life-threatening overdose. The risk of these side effects can increase with a higher dose and longer duration of use.
Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it.
The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent on or addicted to Actimorph if:
If you notice any of the following signs whilst taking Actimorph, it could be a sign that you have become dependent or addicted:
If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (See section 3, If you stop taking Actimorph).
Talk to your doctor or pharmacist before taking Actimorph Orodispersible tablets, especially:
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:
Acute generalized exanthematous pustulosis (AGEP) has been reported in association with Actimorph treatment. Symptoms usually occur within the first 10 days of treatment. Tell your doctor if you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Actimorph or other opioids. Stop using Actimorph and seek medical attention immediately, if you notice any of the following symptoms: blistering, widespread scaly skin or pus-filled spots together with fever.
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.
Contact your doctor if you experience severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever as this could be symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system.
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.
This medicine should be used with caution in the elderly (see section "How to take Actimorph Orodispersible tablets").
Do not give this medicine to children under 6 months of age (see section "Do not take 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:
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.
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.
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 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.
This medicine contains morphine, which is listed as a doping substance. Its use can lead to positive results in anti-doping tests.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Before starting treatment and regularly during treatment, your doctor will discuss with you what you may expect from using Actimorph, when and how long you need to take it, when to contact your doctor, and when you need to stop it (see also, If you stop taking Actimorph, in this section).
The dose will depend on the intensity of your pain and your previous history of the need for analgesics. When treating chronic pain, dose according to a fixed shedule should be given preference.
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.
A reduction in dose is recommended in the elderly (dose reduction such as 2.5-5 mg every 4-6 hours).
This medicine should be administered with particular care in patients with liver or kidney problems.
This medicine should be administered with particular care in patients with a suspected delay in the gastrointestinal passage.
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.
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 orodispersible tablet.
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").
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 and/or suffer from a brain disorder (known as toxic leukoencephalopathy).
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 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.
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using Actimorph and seek medical attention immediately if you notice any of the following symptoms:
Severe skin reaction with blistering, widespread scaly skin, pus-filled spots together with fever. This could be a condition called Acute Generalized Exanthematous Pustulosis (AGEP).
The most serious side effect (uncommon), is a condition where you breathe more slowly or weakly than expected (respiratory depression). Tell your doctor immediately if this happens to you.
This medicine can cause allergic reactions (the frequency of serious allergic reactions is not known). Tell your doctor immediately if you get any sudden wheeziness, difficulties in breathing, dizziness, swelling of the eyelids, face or lips, rash or itching especially those covering your whole body.
The most common side effects of morphine are nausea, vomiting, confusion, constipation and drowsiness.
There is a risk that you may become addicted or reliant on this medicine.
In patients treated with morphine, the following side effects have been reported:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data
If this medicine is stopped abruptly, a withdrawal syndrome may appear: anxiety, irritability, chills, pupil dilation, hot flashes, sweating, tearing, runny nose, nausea, vomiting, abdominal pain, diarrhea, joint pain.
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.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
United Kingdom:
This leaflet was last revised in 03/2025.
C14006 - XXXXX