Sevredol 10 mg, 20 mg and 50 mg tablets
Morphine sulphate
Read all of this leaflet carefully before you start taking this medicine.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Sevredol tablets are and what they are used for
2. Before you take Sevredol tablets
3. How to take Sevredol tablets
4. Possible side effects
5. How to store Sevredol tablets
6. Further information
What Sevredol tablets are and what they are used for
These tablets have been prescribed for you by your doctor to relieve severe pain. They contain the active ingredient morphine which belongs to a group of medicines called strong analgesics or ‘painkillers’.
Before you take Sevredol tablets
Do not take Sevredol tablets if:
- you are allergic (hypersensitive) to morphine or any of the other ingredients of the tablets (see section 6 ‘Further Information’);
- 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;
- you have a head injury that causes a severe headache or makes you feel sick. This is because the tablets may make these symptoms worse or hide the extent of the head injury;
- you have a condition where the small bowel (part of your gut) does not work properly (paralytic ileus), your stomach empties more slowly than it should (delayed gastric emptying) or you have severe pain in your abdomen;
- you have recent onset liver disease;
- you are taking a type of medicine known as a monoamine oxidase inhibitor (examples include tranylcypromide, phenelzine, isocarboxazid, moclobemide and linezolid), or you have taken this type of medicine in the last two weeks;
- the patient is under three years of age.
Take special care with Sevredol tablets
Before treatment with these tablets tell your doctor or pharmacist if you:
- have breathing problems, such as impaired lung function. Your doctor will have told you if you have this condition. Symptoms may include breathlessness and coughing;
- have an under-active thyroid gland (hypothyroidism), kidney or long-term liver problems as you may need a lower dose;
- have a severe headache or feel sick as this may indicate that the pressure in your skull is increased;
- suffer from, or have ever suffered from epilepsy, seizures, fits or convulsions;
- have low blood pressure;
- have a severe heart problem after long-term lung disease (severe cor pulmonale);
- have inflammation of the pancreas (which causes severe pain in the abdomen and back) or problems with your gall bladder;
- have an inflammatory bowel disorder;
- have prostate problems;
- have poor adrenal gland function (your adrenal gland is not working properly which may cause symptoms including weakness, weight loss, dizziness, feeling or being sick);
- are or have ever been addicted to alcohol or drugs;
- have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, upon stopping taking alcohol or drugs.
If you are going to have an operation, please tell the doctor at the hospital that you are taking these tablets.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you take these tablets with some other medicines, the effect of the tablets or the other medicine may be changed.
These tablets must not be used together with a monoamine oxidase inhibitor, or if you have taken this type of medicine in the last two weeks (see section 2 ‘Do not take…’).
Tell your doctor or pharmacist if you are taking:
- medicines to help you sleep (for example tranquillisers, hypnotics or sedatives);
- medicines to treat psychiatric or mental disorders (such as phenothiazines);
- muscle relaxants;
- medicines to treat high blood pressure;
- cimetidine to treat stomach ulcers, indigestion or heartburn;
- other strong analgesics or ‘painkillers’ (such as buprenorphine, nalbuphine or pentazocine);
- rifampicin to treat tuberculosis;
- ritonavir to treat HIV.
Also tell your doctor if you have recently been given an anaesthetic.
Taking Sevredol tablets with alcohol
Drinking alcohol during your treatment with these tablets may make you sleepy. If you are affected you should avoid drinking alcohol.
Pregnancy and breastfeeding
Do not take these tablets if you are pregnant or breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
These tablets may cause a number of side effects such as drowsiness which could affect your ability to drive or use machinery (see section 4 for a full list of side effects). These are usually most noticeable when you first start taking the tablets, or when changing to a higher dose. If you are affected you should not drive or use machinery.
Important information about some of the ingredients of Sevredol tablets
These tablets contain lactose which is a form of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these tablets.
The 20 mg strength tablets contain sunset yellow (E110) which may cause allergic reactions.
How to take Sevredol tablets
Always take the tablets exactly as your doctor has told you. The label on your medicine will tell you how many tablets to take and how often.
Swallow your tablets whole with a glass of water.
You must only take the tablets by mouth. The tablets should never be crushed and injected as this may lead to serious side effects, which may be fatal.
Adults
The usual starting dose is one tablet every 4 hours. Your doctor will decide how many tablets you should take.
Children
Only the 10 mg and 20 mg strength tablets are suitable for children. Children should not be given the 50 mg tablets.
Children 3 to 5 years of age
The usual dose is 5 mg every four hours.
Children 6 to 12 years of age
The usual dose is 5 – 10 mg every four hours.
If you find that you are still in pain whilst taking these tablets discuss this with your doctor.
Do not exceed the dose recommended by your doctor. You should check with your doctor or pharmacist if you are not sure.
If you take more Sevredol tablets than you should or if someone accidentally swallows your tablets
Call your doctor or hospital straight away. People who have taken an overdose may feel very sleepy, sick or dizzy. They may also have breathing difficulties leading to unconsciousness or even death and may need emergency treatment in hospital. When seeking medical attention make sure that you take this leaflet and any remaining tablets with you to show to the doctor.
If you forget to take Sevredol tablets
If you miss a dose you should take it as soon as you remember and then carry on as before. Do not take two doses within 4 hours. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Sevredol tablets
You should not suddenly stop taking these tablets unless your doctor tells you to. If you want to stop taking your tablets, discuss this with your doctor first. They will tell you how to do this, usually by reducing the dose gradually so you do not experience unpleasant effects. Withdrawal symptoms such as agitation, anxiety, shaking or sweating may occur if you suddenly stop taking these tablets.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, these tablets can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions, although serious allergic reactions are uncommon. Tell your doctor immediately if you get any sudden wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, rash or itching especially those covering your whole body.
The most serious side effect is a condition where you breathe more slowly or weakly than expected (respiratory depression).
As with all strong painkillers, there is a risk that you may become addicted or reliant on these tablets.
Common side effects (probably affecting more than 1 in 100 people taking these tablets)
- Constipation (your doctor can prescribe a laxative to overcome this problem).
- Feeling or being sick (this should normally wear off after a few days, however your doctor can prescribe an anti-sickness medicine if it continues to be a problem).
- Drowsiness (this is most likely when you first start taking your tablets or when your dose is increased, but it should wear off after a few days).
- Dry mouth, loss of appetite, indigestion, abdominal pain or discomfort.
- Headache, confusion, difficulty in sleeping, abnormal thoughts.
- A feeling of unusual weakness.
- Difficulty in breathing or wheezing, decreased cough reflex.
- Involuntary muscle contractions or spasms.
- An increase in the severity of symptoms associated with inflammation of the pancreas (severe pain in the abdomen and back).
- Rash or itchy skin.
- Sweating.
Uncommon side effects (probably affecting fewer than 1 in 100 people taking these tablets)
- Gastrointestinal disorders (e.g. upset stomach), changes in taste.
- A feeling of dizziness or ‘spinning’, fainting, seizures, fits or convulsions.
- Agitation, unpleasant or uncomfortable mood, mood changes, hallucinations, a feeling of extreme happiness.
- Generally feeling unwell.
- Tingling or numbness.
- Difficulty in passing urine.
- Impotence, decreased sexual drive, absence of menstrual periods.
- High or low blood pressure, facial flushing (redness of the face).
- A fast or slow heart beat, palpitations.
- Swelling of the hands, ankles or feet.
- Blurred vision, reduction in size of the pupils in the eye.
Uncommonly, the tablets may affect the results of blood tests to check that your liver is working properly.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How to store Sevredol tablets
Keep out of the reach and sight of children.
Do not use any tablets after the expiry date which is stated on the blister and carton. EXP 08 2010 means that you should not take the tablets after the last day of that month i.e. August 2010.
Do not store your tablets above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further information
What Sevredol tablets contain
The active ingredient is morphine sulphate. Each tablet contains 10 mg, 20 mg or 50 mg of morphine sulphate.
The other ingredients are:
- Lactose
- Pregelatinised maize starch
- Povidone
- Magnesium stearate
- Talc
- Macrogol 400
- Hypromellose (E464)
- Titanium dioxide (E171)
The tablets also contain the following colourants:
10 mg – Brilliant blue (E133)
20 mg - Erythrosine (E127) and sunset yellow (E110)
50 mg – Quinoline yellow (E104), indigo carmine (E132) and iron oxide (E172)
What Sevredol tablets look like and the contents of the pack
The tablets have a score line on one side. ‘IR’ and the strength (e.g. 10, 20 etc) are on either side of the score line. The tablets are coloured as follows: 10 mg - blue, 20 mg - pink, 50 mg – pale green.
In each box there are 56 tablets.
Marketing Authorisation Holder and Manufacturer
The tablets are made by Bard Pharmaceuticals Limited for the marketing authorisation holder
This leaflet is also available in large print, Braille or as an audio CD. To request a copy, please call the RNIB Medicine Information line (free of charge) on:
0800 198 5000
You will need to give details of the product name and reference number.
These are as follows:
Product name: Sevredol tablets
Reference number: 16950/0063
This leaflet was last revised in May 2009
Sevredol and the NAPP device (logo) are Registered Trade Marks.
© 2009 Napp Pharmaceuticals Limited
P0075-A R1V3 UK AW 17-03-09 (Approved)
SEVREDOL P0075-A R1V3 UK AW 17-03-09 (Approved) to be checked
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